Panels › Physical Medicine › Product code BXB · Class 1
Exerciser, Powered
Regulation 890.5380
0510(k)s in 12 months (160 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in BXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Allied Associates, Inc. | 9 | 0 |
| Toronto Medical Corp. | 9 | 0 |
| Buckman Co., Inc. | 8 | 0 |
| Invacare Corp. | 8 | 0 |
| Sutter Corp. | 5 | 0 |
| Dyna Flex, Intl. | 4 | 0 |
| Sutter Biomedical, Inc. | 4 | 0 |
| Baltimore Therapeutic Equipment Co. | 3 | 0 |
| Biodex Medical Systems, Inc. | 3 | 0 |
| Danninger Medical Technology, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 1988 | K874884 | MEDTRONIC(R) ORTHOFLEX(TM) Metronic, Inc. | BXB |
| Jan 19, 1988 | K872815 | TRANSJAW(TM) Vitek, Inc. | BXB |
| Dec 10, 1987 | K874196 | POWER EXERCISE EQUIPMENT Arc Motion , Ltd. | BXB |
| Sep 18, 1987 | K872639 | DELUXE MOTORIZED TREADMILL MODEL #FT2300 Invacare Corp. | BXB |
| Sep 18, 1987 | K872638 | MOTORIZED TREADMILL MODEL #FT2200 Invacare Corp. | BXB |
| Sep 18, 1987 | K872586 | ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400 Invacare Corp. | BXB |
| Jun 17, 1987 | K871981 | BILATERAL CONTINUOUS PASSIVE MOTION DEVICE Avec Scientific Design Corp. | BXB |
| Mar 25, 1987 | K871012 | CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD Cropper Medical, Inc. | BXB |
| Mar 16, 1987 | K870402 | MOBILIMB HAND EXERCISER Biodynamic Technologies, Inc. | BXB |
| Feb 26, 1987 | K870510 | DANNIFLEX 400I Buckman Co., Inc. | BXB |
| Dec 2, 1986 | K864427 | KNEECPM Invacare Corp. | BXB |
| Sep 29, 1986 | K863639 | ARTICULAR MOTION DEVICE (AMD4000) Med Surg Designs, Inc. | BXB |
| Jul 24, 1986 | K862730 | DANNIFLEX 400SL Danninger Medical Technology, Inc. | BXB |
| Jul 22, 1986 | K862093 | GINGERBREAD MAN (TM) Southern Pride Manufacturing, Inc. | BXB |
| Jul 15, 1986 | K862314 | HIP CONTINUOUS PASSIVE MOTION MACHINE Richards Medical Co., Inc. | BXB |
| Feb 6, 1986 | K854354 | THE BLEDSOE PASSIVE MOTION EXERCISER Medical Technology and Innovations, Inc. | BXB |
| Oct 16, 1985 | K852977 | KNEE MACHINE Kaiser Medical | BXB |
| Aug 9, 1985 | K852399 | TOTAL CPM Invacare Corp. | BXB |
| Jul 19, 1985 | K852065 | PRESTON LOWER LIMB CPM UNIT Therapeutic Equipment Corp. | BXB |
| Jul 17, 1985 | K851331 | EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) Empi | BXB |
| Jun 28, 1985 | K851177 | UNIVERSAL POWER FLEX Biodynamic Technologies, Inc. | BXB |
| Jun 28, 1985 | K844779 | HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL Roadmaster Corp. | BXB |
| Jun 5, 1985 | K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS Ketronic, Inc., NL | BXB |
| May 17, 1985 | K844118 | THERAPEUTIC LIMB MANIPULATOR Donald E. Redding | BXB |
| May 1, 1985 | K850332 | KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE Richards Medical Co., Inc. | BXB |
| Apr 25, 1985 | K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT Sutter Biomedical, Inc. | BXB |
| Apr 25, 1985 | K850030 | CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE Arc Motion , Ltd. | BXB |
| Apr 1, 1985 | K844995 | SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE Cropper Medical, Inc. | BXB |
| Oct 16, 1984 | K843309 | UNIFLEX DANNINGER Buckman Co., Inc. | BXB |
| Sep 12, 1984 | K843493 | PATIENT GUIDED KNEE EXERCISER Richards Medical Co., Inc. | BXB |
| Aug 8, 1984 | K842882 | ANKLE MOBILIZER Joint Mobilizer Systems, Inc. | BXB |
| Aug 8, 1984 | K842881 | KNEE-HIP MOBILIZER Joint Mobilizer Systems, Inc. | BXB |
| Aug 2, 1984 | K842433 | ALLIED ASSOC. THERAPEUTIC EXERCISE Allied Associates, Inc. | BXB |
| Aug 2, 1984 | K842430 | ALLIED ASSOC. THERAP. EXERCISE EQUIP Allied Associates, Inc. | BXB |
| Aug 2, 1984 | K842429 | ALLIED ASSOC. THERAPEUTIC EXER EQUIP- Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842432 | ALLIED ASSOCIATES THERAPEUTIC EXERSIE Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842431 | ALLIED ASSOC. THERAP. EXERCISE EQUIP- Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842428 | ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842427 | ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842426 | ALLIED ASSOC. THERAPEUTIC EXERICSE Allied Associates, Inc. | BXB |
| Aug 1, 1984 | K842425 | ALLIED ASSOCIATES THERAPEUTIC EXERCISE Allied Associates, Inc. | BXB |
| May 9, 1984 | K841674 | CONTINUOUS PASSIVE MOTION Chattanooga Group, Inc. | BXB |
| Apr 18, 1984 | K841413 | HYDRA-GYM ATHLETICS INC. Hydra Fitness Industries | BXB |
| Jan 30, 1984 | K834203 | FLEXXR* CPM SYSTEM Qarex Laboratories, Inc. | BXB |
| Jul 12, 1983 | K831910 | STRYKER LEG EXERCISER Stryker Corp. | BXB |
| Jun 16, 1983 | K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC Richard'S Medical Equip., Inc. | BXB |
| Mar 24, 1983 | K830316 | UNIFLEX Buckman Consultants | BXB |
| Mar 17, 1983 | K830649 | SUTTER CPM 2000 Sutter Biomedical, Inc. | BXB |
| Mar 8, 1983 | K830369 | POWER FLEX Biodynamic Technologies of Florida | BXB |
| Feb 7, 1983 | K830122 | CONTINUOUS ANATOMICAL PASSIVE EXERCISER Zimmer, Inc. | BXB |
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