FDA Product Code
FDA Product Code BXB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5380
510(k) Clearances — 160 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | 2008-01-25 | Traditional | PDF ↗ |
| K003272 | FLO-BOOT | Discovery Group, LLC | 2001-04-04 | Traditional | PDF ↗ |
| K952975 | ANKLE CALF EXERCISER PHLEBOPUMP | Prevent Products, Inc. | 1996-09-25 | Traditional | PDF ↗ |
| K953456 | E-Z FLEX | Fluid Motion Biotechnologies, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | Traditional | PDF ↗ |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | Traditional | PDF ↗ |
| K951028 | HAMEX TWO | Northern Orthopaedic Products, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K950755 | FLEXMATE K500 | Breg, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | 1995-09-13 | Traditional | PDF ↗ |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K945824 | GALAXY MD SERIES THERAPYPOOLS | Galaxy Aquatics, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944819 | KRDL 2000 | Physicians Consulting, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | Sutter Corp. | 1995-02-27 | Traditional | PDF ↗ |
| K945121 | A3 ANKLE CPM UNIT | Toronto Medical, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K940455 | LATERAL FLEXION MACHINE | Rehab, Inc. | 1995-01-12 | Traditional | PDF ↗ |
| K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) | Swimex Systems | 1995-01-09 | Traditional | PDF ↗ |
| K935587 | MULTILINK SHOULDER CPM UNIT | Toronto Medical Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K935509 | HYDROTRACK | Ferno Ille | 1994-10-03 | Traditional | PDF ↗ |
| K935216 | SEMI-RECUMBENT CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K935061 | LOWER BODY CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | Biodex Medical Systems, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K942618 | ANKLE CALF EXERCISER | Prevent Products, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. | Jace Systems, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K926136 | WATSYSTEM | Watsystem Div. of Itc | 1994-05-20 | Traditional | PDF ↗ |
| K931128 | BASIC SHOULDER CPM | Danninger Medical Technology, Inc. | 1994-05-06 | Traditional | PDF ↗ |
| K935467 | R & D BATTERIES, INC. PART NUMBER 5447 | R & D Batteries, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K935188 | STRETCHPOWER | Orthopedic Development, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K934175 | STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER | Orthopedic Development, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K935808 | REVOLUTION LOWER LIMB CPM UNIT | Toronto Medical, Inc. | 1994-03-18 | Traditional | PDF ↗ |
| K933394 | DANNIFLEX CPM 600 | Danninger Medical Technology, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K930780 | ADV400 TOE CPM | Advanced Kinetics, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | Henley Intl. | 1994-02-04 | Traditional | PDF ↗ |
| K931555 | ARTROMOT K2 CPM | Ormed Mfg., Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K931736 | M-FLEX 5000 C3PMD | Medical Systems Corp. | 1994-01-27 | Traditional | PDF ↗ |
| K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE | Sgarlato Laboratories, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K933311 | MOTORIZED ELECTRIC PARALLEL BARS | Midland Mfg. Co. | 1994-01-26 | Traditional | PDF ↗ |
| K931723 | HYDRO-TRED/AIR POWERED TREADMILL | Santa FE Swim Systems | 1994-01-26 | Traditional | PDF ↗ |
| K925270 | EX N' FLEX EF-200 | Tecogics Scientific , Ltd. | 1993-07-21 | Traditional | PDF ↗ |
| K924513 | LIDO(R) LINEA | Loredan Biomedical, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K925977 | PARAMED FLEXION-EXTENSION MACHINE | Paramed Services, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K925271 | REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE | Repex Intl., Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K925807 | AQUACISER IN-POOL TREADMILL | Aquaciser, Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K925926 | MOBILIMB T1 TOE CPM UNIT | Toronto Medical Corp. | 1993-03-22 | Traditional | PDF ↗ |
| K924484 | ARTROMOT MULTI DIRECTIONAL ANKLE CPM | Buckman Co., Inc. | 1993-03-22 | Traditional | PDF ↗ |
| K925666 | THERAPACER 3000 | Kvm Technologies, Inc. | 1993-03-09 | Traditional | PDF ↗ |
| K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT | Sutter Corp. | 1993-02-22 | Traditional | PDF ↗ |
| K925043 | ELBOW CPM ORTHOSIS | Electrobionics Corp. | 1993-02-12 | Traditional | PDF ↗ |
| K923857 | ARTROMOT SB ELBOW ATTACHMENT | Buckman Co., Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K923805 | POWER PILLOW | Nova Teknic, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K923494 | PARAMED LATERAL FLEXION MACHINE | Paramed Div | 1992-11-09 | Traditional | PDF ↗ |
| K921348 | OIC MODEL J4 TMJ CPM | Lm Product Design, Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K923217 | DANNIFLEX CPM 2000 | Buckman Co., Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K923216 | DANNINFLEX CPM 800 | Buckman Co., Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K922493 | AMERICAN MEDICAL MFG. LUMBAR CPM | American Medical Corp. | 1992-07-27 | Traditional | PDF ↗ |
| K920686 | ORTHO-PLEX-REHABILITATION SYSTEM | Plexus Intl., Inc. | 1992-06-11 | Traditional | PDF ↗ |
| K922185 | JACE KNEE EXTENSION SYSTEM -- MODIFICATION | Jace Systems, Inc. | 1992-06-11 | Traditional | PDF ↗ |
| K921323 | CERVICAL PASSIVE MOTION | Rehabilitative Resources, Inc. | 1992-06-03 | Traditional | PDF ↗ |
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | U.S. Mfg. & Management, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K920519 | LUMBAR CPM | Rehabilitative Resources, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K920270 | CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY | Sports Medical Synergy | 1992-03-02 | Traditional | PDF ↗ |
| K920380 | JACE MODEL W550 WRIST CPM DEVICE | Jace Systems, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K914860 | SUTTER MODEL 10000 LEG CPM DEVICE | Sutter Corp. | 1992-01-08 | Traditional | PDF ↗ |
| K914394 | BACK MASTER | Progressive Electrical Therapeutics | 1991-11-13 | Traditional | PDF ↗ |
| K913227 | JACE MODEL T300 TOE CPM DEVICE | Thera Kinetics, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K912537 | JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION | Thera Kinetics, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K912086 | FMA TRANSLATOR | Normandie Group, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K904963 | EXTEND TRACK UNIT | Anthony Chiropractic Clinic, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K905718 | ROMFLEX | Paraflex Corp. | 1991-02-19 | Traditional | PDF ↗ |
| K904735 | DANNIFLEX MODEL 500TM CPM | Buckman Co., Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K910150 | ROMFLEX REHAB EQUIP EXTREMITIES UNIT | Dyna Flex, Intl. | 1991-01-23 | Traditional | PDF ↗ |
| K910151 | ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT | Dyna Flex, Intl. | 1991-01-18 | Traditional | PDF ↗ |
| K910026 | ATI MEDICAL COMFORT PLUS CPM PAD | Ati Medical, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K910149 | ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT | Dyna Flex, Intl. | 1991-01-18 | Traditional | PDF ↗ |
| K905299 | ROMFLEX REHABILITATION EQUIPMENT | Dyna Flex, Intl. | 1990-12-31 | Traditional | PDF ↗ |
| K893924 | MOTO-MED RF-II AND PICO | Holl Meditronics, Inc. | 1990-11-27 | Traditional | PDF ↗ |
| K903851 | CLUB FOOT CPM MACHINE | Smith & Nephew Richards, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K903467 | JACE MODEL 100 KNEE CPM DEVICE | Thera Kinetics, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K902707 | MODEL 9000 AT ANKLE CPM DEVICE | Sutter Corp. | 1990-07-25 | Traditional | PDF ↗ |
| K902452 | CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER | Berner Assoc., Inc. | 1990-06-11 | Traditional | PDF ↗ |
| K900795 | MOBILIMB L4 LOWER LIMB CPM UNIT | Toronto Medical Corp. | 1990-03-12 | Traditional | PDF ↗ |
| K900466 | MOBILIMB W1 WRIST CPM UNIT | Toronto Medical Corp. | 1990-03-12 | Traditional | PDF ↗ |
| K895720 | MOBILIMB J1 TMJ CPM UNIT | Toronto Medical Corp. | 1990-01-04 | Traditional | PDF ↗ |
| K894907 | MARK IV HAND, THUMB AND WRIST (CPM) UNIT | Innovative Medical Engineering, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K895015 | ARTROMOT(TM) CPM DEVICES | Buckman Co., Inc. | 1989-09-11 | Traditional | PDF ↗ |
| K891345 | MOBILIMB CPM SHOULDER UNIT | Toronto Medical Corp. | 1989-04-24 | Traditional | PDF ↗ |
| K890838 | REHABOT-YM | Imex Health, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K885182 | TOTAL KNEE CPM | Invacare Corp. | 1989-03-15 | Traditional | PDF ↗ |
| K890607 | SUTTER HOSPITAL CPM | Sutter Corp. | 1989-02-27 | Traditional | PDF ↗ |
| K885095 | SUPREME TONING SYSTEMS | Supreme Toning Systems | 1989-02-06 | Traditional | PDF ↗ |
| K890200 | PNEUMATIC DORSIFLEXOR | Medical Flotation Systems, Inc. | 1989-02-03 | Traditional | PDF ↗ |
| K881314 | PROMO-RIST C.P.M. | Professional Motion, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K882406 | CONVA-LIFT | Numerical Concepts, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K882916 | MOTORIZED PARALLEL BAR, MODEL 110 | Tri W-G, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K880865 | RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 | Invacare Corp. | 1988-05-02 | Traditional | PDF ↗ |
| K873658 | ANKLE REFLEX TREATMENT UNIT (ARTU) | Universal Gym Equipment, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K880092 | RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 | Invacare Corp. | 1988-04-11 | Traditional | PDF ↗ |
Product code BXB · Class I · Physical Medicine. Data: openFDA.