FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K930780 |
ADVANCED KINETICS, INC. |
ADV400 TOE CPM |
02/17/1994 |
K842430 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAP. EXERCISE EQUIP |
08/02/1984 |
K842431 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAP. EXERCISE EQUIP- |
08/01/1984 |
K842429 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAPEUTIC EXER EQUIP- |
08/02/1984 |
K842428 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP |
08/01/1984 |
K842433 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAPEUTIC EXERCISE |
08/02/1984 |
K842427 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP |
08/01/1984 |
K842426 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOC. THERAPEUTIC EXERICSE |
08/01/1984 |
K842425 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOCIATES THERAPEUTIC EXERCISE |
08/01/1984 |
K842432 |
ALLIED ASSOCIATES, INC. |
ALLIED ASSOCIATES THERAPEUTIC EXERSIE |
08/01/1984 |
K072887 |
ALTER-G, INC. |
G-TRAINER MEDICAL |
01/25/2008 |
K922493 |
AMERICAN MEDICAL CORP. |
AMERICAN MEDICAL MFG. LUMBAR CPM |
07/27/1992 |
K904963 |
ANTHONY CHIROPRACTIC CLINIC, INC. |
EXTEND TRACK UNIT |
06/28/1991 |
K925807 |
AQUACISER, INC. |
AQUACISER IN-POOL TREADMILL |
03/24/1993 |
K945733 |
AQUARIUS ELECTRONICS, INC. |
AQUAHAB, MODEL 120-72-101 |
09/15/1995 |
K850030 |
ARC MOTION LTD. |
CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE |
04/25/1985 |
K874196 |
ARC MOTION LTD. |
POWER EXERCISE EQUIPMENT |
12/10/1987 |
K910026 |
ATI MEDICAL, INC. |
ATI MEDICAL COMFORT PLUS CPM PAD |
01/18/1991 |
K871981 |
AVEC SCIENTIFIC DESIGN CORP. |
BILATERAL CONTINUOUS PASSIVE MOTION DEVICE |
06/17/1987 |
K955105 |
BALTIMORE THERAPEUTIC EQUIPMENT CO. |
BTE CPM-10 |
12/29/1995 |
K955106 |
BALTIMORE THERAPEUTIC EQUIPMENT CO. |
BTE CPM-20 |
12/29/1995 |
K800007 |
BALTIMORE THERAPEUTIC EQUIPMENT CO. |
WORK SIMULATOR |
01/21/1980 |
K902452 |
BERNER ASSOC., INC. |
CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER |
06/11/1990 |
K935061 |
BIODEX MEDICAL SYSTEMS, INC. |
LOWER BODY CYCLES |
09/16/1994 |
K935216 |
BIODEX MEDICAL SYSTEMS, INC. |
SEMI-RECUMBENT CYCLES |
09/16/1994 |
K935520 |
BIODEX MEDICAL SYSTEMS, INC. |
UPPER BODY CYCLES (110 VOLT)/(220 VOLT) |
09/16/1994 |
K830369 |
BIODYNAMIC TECHNOLOGIES OF FLORIDA |
POWER FLEX |
03/08/1983 |
K870402 |
BIODYNAMIC TECHNOLOGIES, INC. |
MOBILIMB HAND EXERCISER |
03/16/1987 |
K851177 |
BIODYNAMIC TECHNOLOGIES, INC. |
UNIVERSAL POWER FLEX |
06/28/1985 |
K950755 |
BREG, INC. |
FLEXMATE K500 |
10/05/1995 |
K924484 |
BUCKMAN CO., INC. |
ARTROMOT MULTI DIRECTIONAL ANKLE CPM |
03/22/1993 |
K923857 |
BUCKMAN CO., INC. |
ARTROMOT SB ELBOW ATTACHMENT |
02/12/1993 |
K895015 |
BUCKMAN CO., INC. |
ARTROMOT(TM) CPM DEVICES |
09/11/1989 |
K870510 |
BUCKMAN CO., INC. |
DANNIFLEX 400I |
02/26/1987 |
K923217 |
BUCKMAN CO., INC. |
DANNIFLEX CPM 2000 |
08/03/1992 |
K904735 |
BUCKMAN CO., INC. |
DANNIFLEX MODEL 500TM CPM |
01/30/1991 |
K923216 |
BUCKMAN CO., INC. |
DANNINFLEX CPM 800 |
08/03/1992 |
K843309 |
BUCKMAN CO., INC. |
UNIFLEX DANNINGER |
10/16/1984 |
K830316 |
BUCKMAN CONSULTANTS |
UNIFLEX |
03/24/1983 |
K841674 |
CHATTANOOGA GROUP, INC. |
CONTINUOUS PASSIVE MOTION |
05/09/1984 |
K871012 |
CROPPER MEDICAL, INC. |
CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD |
03/25/1987 |
K844995 |
CROPPER MEDICAL, INC. |
SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE |
04/01/1985 |
K931128 |
DANNINGER MEDICAL TECHNOLOGY, INC. |
BASIC SHOULDER CPM |
05/06/1994 |
K862730 |
DANNINGER MEDICAL TECHNOLOGY, INC. |
DANNIFLEX 400SL |
07/24/1986 |
K933394 |
DANNINGER MEDICAL TECHNOLOGY, INC. |
DANNIFLEX CPM 600 |
03/11/1994 |
K003272 |
DISCOVERY GROUP LLC. |
FLO-BOOT |
04/04/2001 |
K844118 |
DONALD E. REDDING |
THERAPEUTIC LIMB MANIPULATOR |
05/17/1985 |
K910151 |
DYNA FLEX, INTL. |
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT |
01/18/1991 |
K910150 |
DYNA FLEX, INTL. |
ROMFLEX REHAB EQUIP EXTREMITIES UNIT |
01/23/1991 |
K910149 |
DYNA FLEX, INTL. |
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT |
01/18/1991 |
K905299 |
DYNA FLEX, INTL. |
ROMFLEX REHABILITATION EQUIPMENT |
12/31/1990 |
K925043 |
ELECTROBIONICS CORP. |
ELBOW CPM ORTHOSIS |
02/12/1993 |
K851331 |
EMPI |
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) |
07/17/1985 |
K945690 |
ERGOMEDICS, INC. |
BACKCYCLER CPM(TM) |
06/22/1995 |
K935509 |
FERNO ILLE |
HYDROTRACK |
10/03/1994 |
K953456 |
FLUID MOTION BIOTECHNOLOGIES, INC. |
E-Z FLEX |
01/26/1996 |
K945824 |
GALAXY AQUATICS, INC. |
GALAXY MD SERIES THERAPYPOOLS |
04/05/1995 |
K926313 |
HENLEY INTL. |
COMPUTERIZED TESTING AND EXERCISE SYSTEMS |
02/04/1994 |
K893924 |
HOLL MEDITRONICS, INC. |
MOTO-MED "RF-II" AND "PICO" |
11/27/1990 |
K841413 |
HYDRA FITNESS INDUSTRIES |
HYDRA-GYM ATHLETICS INC. |
04/18/1984 |
K890838 |
IMEX HEALTH, INC. |
REHABOT-YM |
03/23/1989 |
K821016 |
INDUSTRIAL ENERGY SPECIALISTS, INC. |
QUADRUPLE JOGGER EXERCISER |
04/26/1982 |
K894907 |
INNOVATIVE MEDICAL ENGINEERING, INC. |
"MARK IV" HAND, THUMB AND WRIST (CPM) UNIT |
10/06/1989 |
K872639 |
INVACARE CORP. |
DELUXE MOTORIZED TREADMILL MODEL #FT2300 |
09/18/1987 |
K872586 |
INVACARE CORP. |
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400 |
09/18/1987 |
K864427 |
INVACARE CORP. |
KNEECPM |
12/02/1986 |
K872638 |
INVACARE CORP. |
MOTORIZED TREADMILL MODEL #FT2200 |
09/18/1987 |
K880865 |
INVACARE CORP. |
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 |
05/02/1988 |
K880092 |
INVACARE CORP. |
RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 |
04/11/1988 |
K852399 |
INVACARE CORP. |
TOTAL CPM |
08/09/1985 |
K885182 |
INVACARE CORP. |
TOTAL KNEE CPM |
03/15/1989 |
K933059 |
JACE SYSTEMS, INC. |
ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. |
06/22/1994 |
K922185 |
JACE SYSTEMS, INC. |
JACE KNEE EXTENSION SYSTEM -- MODIFICATION |
06/11/1992 |
K920380 |
JACE SYSTEMS, INC. |
JACE MODEL W550 WRIST CPM DEVICE |
02/11/1992 |
K842882 |
JOINT MOBILIZER SYSTEMS, INC. |
ANKLE MOBILIZER |
08/08/1984 |
K842881 |
JOINT MOBILIZER SYSTEMS, INC. |
KNEE-HIP MOBILIZER |
08/08/1984 |
K852977 |
KAISER MEDICAL |
KNEE MACHINE |
10/16/1985 |
K850871 |
KETRONIC, INC. |
TREDBAND TYPE I, IT, II & III - TREADMILLS |
06/05/1985 |
K925666 |
KVM TECHNOLOGIES, INC. |
THERAPACER 3000 |
03/09/1993 |
K921348 |
LM PRODUCT DESIGN, INC. |
OIC MODEL J4 TMJ CPM |
08/05/1992 |
K924513 |
LOREDAN BIOMEDICAL, INC. |
LIDO(R) LINEA |
03/31/1993 |
K863639 |
MED SURG DESIGNS, INC. |
ARTICULAR MOTION DEVICE (AMD4000) |
09/29/1986 |
K890200 |
MEDICAL FLOTATION SYSTEMS, INC. |
PNEUMATIC DORSIFLEXOR |
02/03/1989 |
K820476 |
MEDICAL GRAPHICS CORP. |
KEM-2 |
03/08/1982 |
K931736 |
MEDICAL SYSTEMS CORP. |
M-FLEX 5000 C3PMD |
01/27/1994 |
K854354 |
MEDICAL TECHNOLOGY AND INNOVATIONS, INC. |
THE BLEDSOE PASSIVE MOTION EXERCISER |
02/06/1986 |
K874884 |
METRONIC, INC. |
MEDTRONIC(R) ORTHOFLEX(TM) |
01/28/1988 |
K933311 |
MIDLAND MFG. CO. |
MOTORIZED ELECTRIC PARALLEL BARS |
01/26/1994 |
K912086 |
NORMANDIE GROUP, INC. |
FMA TRANSLATOR |
08/07/1991 |
K946169 |
NORTH ATLANTIC REHABILITATION, INC, |
ACTIC 2002 |
06/15/1995 |
K951029 |
NORTHERN ORTHOPAEDIC PRODUCTS, INC. |
HAMEX ONE |
09/15/1995 |
K951028 |
NORTHERN ORTHOPAEDIC PRODUCTS, INC. |
HAMEX TWO |
12/11/1995 |
K923805 |
NOVA TEKNIC, INC. |
POWER PILLOW |
02/12/1993 |
K882406 |
NUMERICAL CONCEPTS, INC. |
CONVA-LIFT |
11/30/1988 |
K810238 |
O'NEILL |
SUPINE STRESS SYSTEM |
02/13/1981 |
K931555 |
ORMED MFG., INC. |
ARTROMOT K2 CPM |
01/31/1994 |
K935188 |
ORTHOPEDIC DEVELOPMENT, INC. |
STRETCHPOWER |
03/24/1994 |
K934175 |
ORTHOPEDIC DEVELOPMENT, INC. |
STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER |
03/24/1994 |
K941128 |
OSTEONICS CORP. |
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS |
12/08/1994 |
K905718 |
PARAFLEX CORP. |
ROMFLEX |
02/19/1991 |
K923494 |
PARAMED DIV |
PARAMED LATERAL FLEXION MACHINE |
11/09/1992 |
K925977 |
PARAMED SERVICES, INC. |
PARAMED FLEXION-EXTENSION MACHINE |
03/31/1993 |
K952369 |
PHYSICIANS CONSULTING, INC. |
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE |
08/07/1995 |
K944819 |
PHYSICIANS CONSULTING, INC. |
KRDL 2000 |
03/10/1995 |
K920686 |
PLEXUS INTL., INC. |
ORTHO-PLEX-REHABILITATION SYSTEM |
06/11/1992 |
K942618 |
PREVENT PRODUCTS, INC. |
ANKLE CALF EXERCISER |
06/22/1994 |
K952975 |
PREVENT PRODUCTS, INC. |
ANKLE CALF EXERCISER PHLEBOPUMP |
09/25/1996 |
K881314 |
PROFESSIONAL MOTION, INC. |
PROMO-RIST C.P.M. |
01/13/1989 |
K914394 |
PROGRESSIVE ELECTRICAL THERAPEUTICS |
BACK MASTER |
11/13/1991 |
K834203 |
QAREX LABORATORIES, INC. |
FLEXXR* CPM SYSTEM |
01/30/1984 |
K935467 |
R & D BATTERIES, INC. |
R & D BATTERIES, INC. PART NUMBER 5447 |
04/19/1994 |
K940455 |
REHAB, INC. |
LATERAL FLEXION MACHINE |
01/12/1995 |
K921323 |
REHABILITATIVE RESOURCES, INC. |
CERVICAL PASSIVE MOTION |
06/03/1992 |
K920519 |
REHABILITATIVE RESOURCES, INC. |
LUMBAR CPM |
03/13/1992 |
K925271 |
REPEX INTL., INC. |
REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE |
03/31/1993 |
K830793 |
RICHARD'S MEDICAL EQUIP., INC. |
PATIENT GUIDED ELBOW & SHOULDER EXERC |
06/16/1983 |
K820120 |
RICHARD'S MEDICAL EQUIP., INC. |
PATIENT GUIDED KNEE EXERCISER |
01/29/1982 |
K862314 |
RICHARDS MEDICAL CO., INC. |
HIP CONTINUOUS PASSIVE MOTION MACHINE |
07/15/1986 |
K850332 |
RICHARDS MEDICAL CO., INC. |
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE |
05/01/1985 |
K843493 |
RICHARDS MEDICAL CO., INC. |
PATIENT GUIDED KNEE EXERCISER |
09/12/1984 |
K844779 |
ROADMASTER CORP. |
HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL |
06/28/1985 |
K931723 |
SANTA FE SWIM SYSTEMS |
HYDRO-TRED/AIR POWERED TREADMILL |
01/26/1994 |
K926262 |
SGARLATO LABORATORIES, INC. |
FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE |
01/26/1994 |
K903851 |
SMITH & NEPHEW RICHARDS, INC. |
CLUB FOOT CPM MACHINE |
10/19/1990 |
K862093 |
SOUTHERN PRIDE MANUFACTURING, INC. |
GINGERBREAD MAN (TM) |
07/22/1986 |
K920270 |
SPORTS MEDICAL SYNERGY |
CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY |
03/02/1992 |
K831910 |
STRYKER CORP. |
STRYKER LEG EXERCISER |
07/12/1983 |
K885095 |
SUPREME TONING SYSTEMS |
SUPREME TONING SYSTEMS |
02/06/1989 |
K820083 |
SUTTER BIOMEDICAL, INC. |
SUTTER CPM |
01/28/1982 |
K823539 |
SUTTER BIOMEDICAL, INC. |
SUTTER CPM |
01/14/1983 |
K830649 |
SUTTER BIOMEDICAL, INC. |
SUTTER CPM 2000 |
03/17/1983 |
K850274 |
SUTTER BIOMEDICAL, INC. |
SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT |
04/25/1985 |
K924654 |
SUTTER CORP. |
FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT |
02/22/1993 |
K902707 |
SUTTER CORP. |
MODEL 9000 AT ANKLE CPM DEVICE |
07/25/1990 |
K890607 |
SUTTER CORP. |
SUTTER HOSPITAL CPM |
02/27/1989 |
K914860 |
SUTTER CORP. |
SUTTER MODEL 10000 LEG CPM DEVICE |
01/08/1992 |
K945221 |
SUTTER CORP. |
SUTTER MODEL 6000 HAND CPM DEVICE |
02/27/1995 |
K935011 |
SWIMEX SYSTEMS |
SWIMEX MULTIDEPTH POOL (MODEL 600T) |
01/09/1995 |
K823495 |
SYNTHES (USA) |
MOBILIMB-CPM UPPER/LOWER LIMB DEVICE |
01/21/1983 |
K925270 |
TECOGICS SCIENTIFIC LTD. |
EX N' FLEX EF-200 |
07/21/1993 |
K903467 |
THERA KINETICS, INC. |
JACE MODEL 100 KNEE CPM DEVICE |
08/10/1990 |
K912537 |
THERA KINETICS, INC. |
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION |
08/16/1991 |
K913227 |
THERA KINETICS, INC. |
JACE MODEL T300 TOE CPM DEVICE |
08/16/1991 |
K852065 |
THERAPEUTIC EQUIPMENT CORP. |
PRESTON LOWER LIMB CPM UNIT |
07/19/1985 |
K891345 |
TORONTO MEDICAL CORP. |
MOBILIMB CPM SHOULDER UNIT |
04/24/1989 |
K895720 |
TORONTO MEDICAL CORP. |
MOBILIMB J1 TMJ CPM UNIT |
01/04/1990 |
K900795 |
TORONTO MEDICAL CORP. |
MOBILIMB L4 LOWER LIMB CPM UNIT |
03/12/1990 |
K925926 |
TORONTO MEDICAL CORP. |
MOBILIMB T1 TOE CPM UNIT |
03/22/1993 |
K900466 |
TORONTO MEDICAL CORP. |
MOBILIMB W1 WRIST CPM UNIT |
03/12/1990 |
K935587 |
TORONTO MEDICAL CORP. |
MULTILINK SHOULDER CPM UNIT |
12/14/1994 |
K950682 |
TORONTO MEDICAL CORP. |
W2 WRIST CPM UNIT |
09/13/1995 |
K945121 |
TORONTO MEDICAL, INC. |
A3 ANKLE CPM UNIT |
02/17/1995 |
K935808 |
TORONTO MEDICAL, INC. |
REVOLUTION LOWER LIMB CPM UNIT |
03/18/1994 |
K822031 |
TRI W-G, INC. |
AUTORANGE MODEL 205 |
07/26/1982 |
K882916 |
TRI W-G, INC. |
MOTORIZED PARALLEL BAR, MODEL 110 |
07/28/1988 |
K920860 |
U.S. MFG. & MANAGEMENT, INC. |
CONTROLLED PASSIVE MOTION MACHINE |
04/02/1992 |
K873658 |
UNIVERSAL GYM EQUIPMENT, INC. |
ANKLE REFLEX TREATMENT UNIT (ARTU) |
04/21/1988 |
K872815 |
VITEK, INC. |
TRANSJAW(TM) |
01/19/1988 |
K822212 |
W.R. MCCULLIN |
"MOTORIZED EXERCISER |
08/31/1982 |
K926136 |
WATSYSTEM DIV. OF ITC |
WATSYSTEM |
05/20/1994 |
K830122 |
ZIMMER, INC. |
CONTINUOUS ANATOMICAL PASSIVE EXERCISER |
02/07/1983 |