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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K874884 | MEDTRONIC(R) ORTHOFLEX(TM) | Metronic, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K872815 | TRANSJAW(TM) | Vitek, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K874196 | POWER EXERCISE EQUIPMENT | Arc Motion , Ltd. | 1987-12-10 | Traditional | PDF ↗ |
| K872639 | DELUXE MOTORIZED TREADMILL MODEL #FT2300 | Invacare Corp. | 1987-09-18 | Traditional | PDF ↗ |
| K872586 | ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400 | Invacare Corp. | 1987-09-18 | Traditional | PDF ↗ |
| K872638 | MOTORIZED TREADMILL MODEL #FT2200 | Invacare Corp. | 1987-09-18 | Traditional | PDF ↗ |
| K871981 | BILATERAL CONTINUOUS PASSIVE MOTION DEVICE | Avec Scientific Design Corp. | 1987-06-17 | Traditional | PDF ↗ |
| K871012 | CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD | Cropper Medical, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K870402 | MOBILIMB HAND EXERCISER | Biodynamic Technologies, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K870510 | DANNIFLEX 400I | Buckman Co., Inc. | 1987-02-26 | Traditional | PDF ↗ |
| K864427 | KNEECPM | Invacare Corp. | 1986-12-02 | Traditional | PDF ↗ |
| K863639 | ARTICULAR MOTION DEVICE (AMD4000) | Med Surg Designs, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862730 | DANNIFLEX 400SL | Danninger Medical Technology, Inc. | 1986-07-24 | Traditional | PDF ↗ |
| K862093 | GINGERBREAD MAN (TM) | Southern Pride Manufacturing, Inc. | 1986-07-22 | Traditional | PDF ↗ |
| K862314 | HIP CONTINUOUS PASSIVE MOTION MACHINE | Richards Medical Co., Inc. | 1986-07-15 | Traditional | PDF ↗ |
| K854354 | THE BLEDSOE PASSIVE MOTION EXERCISER | Medical Technology and Innovations, Inc. | 1986-02-06 | Traditional | PDF ↗ |
| K852977 | KNEE MACHINE | Kaiser Medical | 1985-10-16 | Traditional | PDF ↗ |
| K852399 | TOTAL CPM | Invacare Corp. | 1985-08-09 | Traditional | PDF ↗ |
| K852065 | PRESTON LOWER LIMB CPM UNIT | Therapeutic Equipment Corp. | 1985-07-19 | Traditional | PDF ↗ |
| K851331 | EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) | Empi | 1985-07-17 | Traditional | PDF ↗ |
| K851177 | UNIVERSAL POWER FLEX | Biodynamic Technologies, Inc. | 1985-06-28 | Traditional | PDF ↗ |
| K844779 | HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL | Roadmaster Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | Ketronic, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K844118 | THERAPEUTIC LIMB MANIPULATOR | Donald E. Redding | 1985-05-17 | Traditional | PDF ↗ |
| K850332 | KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE | Richards Medical Co., Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K850030 | CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE | Arc Motion , Ltd. | 1985-04-25 | Traditional | PDF ↗ |
| K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT | Sutter Biomedical, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K844995 | SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE | Cropper Medical, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K843309 | UNIFLEX DANNINGER | Buckman Co., Inc. | 1984-10-16 | Traditional | PDF ↗ |
| K843493 | PATIENT GUIDED KNEE EXERCISER | Richards Medical Co., Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K842881 | KNEE-HIP MOBILIZER | Joint Mobilizer Systems, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K842882 | ANKLE MOBILIZER | Joint Mobilizer Systems, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K842433 | ALLIED ASSOC. THERAPEUTIC EXERCISE | Allied Associates, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K842429 | ALLIED ASSOC. THERAPEUTIC EXER EQUIP- | Allied Associates, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K842430 | ALLIED ASSOC. THERAP. EXERCISE EQUIP | Allied Associates, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K842425 | ALLIED ASSOCIATES THERAPEUTIC EXERCISE | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842428 | ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842432 | ALLIED ASSOCIATES THERAPEUTIC EXERSIE | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842431 | ALLIED ASSOC. THERAP. EXERCISE EQUIP- | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842426 | ALLIED ASSOC. THERAPEUTIC EXERICSE | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842427 | ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP | Allied Associates, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K841674 | CONTINUOUS PASSIVE MOTION | Chattanooga Group, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841413 | HYDRA-GYM ATHLETICS INC. | Hydra Fitness Industries | 1984-04-18 | Traditional | PDF ↗ |
| K834203 | FLEXXR* CPM SYSTEM | Qarex Laboratories, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K831910 | STRYKER LEG EXERCISER | Stryker Corp. | 1983-07-12 | Traditional | PDF ↗ |
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Richard'S Medical Equip., Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K830316 | UNIFLEX | Buckman Consultants | 1983-03-24 | Traditional | PDF ↗ |
| K830649 | SUTTER CPM 2000 | Sutter Biomedical, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830369 | POWER FLEX | Biodynamic Technologies of Florida | 1983-03-08 | Traditional | PDF ↗ |
| K830122 | CONTINUOUS ANATOMICAL PASSIVE EXERCISER | Zimmer, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K823495 | MOBILIMB-CPM UPPER/LOWER LIMB DEVICE | Synthes (Usa) | 1983-01-21 | Traditional | PDF ↗ |
| K823539 | SUTTER CPM | Sutter Biomedical, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K822212 | MOTORIZED EXERCISER | W.R. Mccullin | 1982-08-31 | Traditional | PDF ↗ |
| K822031 | AUTORANGE MODEL 205 | Tri W-G, Inc. | 1982-07-26 | Traditional | PDF ↗ |
| K821016 | QUADRUPLE JOGGER EXERCISER | Industrial Energy Specialists, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K820476 | KEM-2 | Medical Graphics Corp. | 1982-03-08 | Traditional | PDF ↗ |
| K820120 | PATIENT GUIDED KNEE EXERCISER | Richard'S Medical Equip., Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K820083 | SUTTER CPM | Sutter Biomedical, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K810238 | SUPINE STRESS SYSTEM | O'Neill | 1981-02-13 | Traditional | PDF ↗ |
| K800007 | WORK SIMULATOR | Baltimore Therapeutic Equipment Co. | 1980-01-21 | Traditional | PDF ↗ |
Product code BXB · Class I · Physical Medicine. Data: openFDA.