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 |
|---|---|---|---|
| Feb 12, 1993 | K925043 | ELBOW CPM ORTHOSIS Electrobionics Corp. | BXB |
| Feb 12, 1993 | K923857 | ARTROMOT SB ELBOW ATTACHMENT Buckman Co., Inc. | BXB |
| Feb 12, 1993 | K923805 | POWER PILLOW Nova Teknic, Inc. | BXB |
| Nov 9, 1992 | K923494 | PARAMED LATERAL FLEXION MACHINE Paramed Div | BXB |
| Aug 5, 1992 | K921348 | OIC MODEL J4 TMJ CPM Lm Product Design, Inc. | BXB |
| Aug 3, 1992 | K923217 | DANNIFLEX CPM 2000 Buckman Co., Inc. | BXB |
| Aug 3, 1992 | K923216 | DANNINFLEX CPM 800 Buckman Co., Inc. | BXB |
| Jul 27, 1992 | K922493 | AMERICAN MEDICAL MFG. LUMBAR CPM American Medical Corp. | BXB |
| Jun 11, 1992 | K922185 | JACE KNEE EXTENSION SYSTEM -- MODIFICATION Jace Systems, Inc. | BXB |
| Jun 11, 1992 | K920686 | ORTHO-PLEX-REHABILITATION SYSTEM Plexus Intl., Inc. | BXB |
| Jun 3, 1992 | K921323 | CERVICAL PASSIVE MOTION Rehabilitative Resources, Inc. | BXB |
| Apr 2, 1992 | K920860 | CONTROLLED PASSIVE MOTION MACHINE U.S. Mfg. & Management, Inc. | BXB |
| Mar 13, 1992 | K920519 | LUMBAR CPM Rehabilitative Resources, Inc. | BXB |
| Mar 2, 1992 | K920270 | CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY Sports Medical Synergy | BXB |
| Feb 11, 1992 | K920380 | JACE MODEL W550 WRIST CPM DEVICE Jace Systems, Inc. | BXB |
| Jan 8, 1992 | K914860 | SUTTER MODEL 10000 LEG CPM DEVICE Sutter Corp. | BXB |
| Nov 13, 1991 | K914394 | BACK MASTER Progressive Electrical Therapeutics | BXB |
| Aug 16, 1991 | K913227 | JACE MODEL T300 TOE CPM DEVICE Thera Kinetics, Inc. | BXB |
| Aug 16, 1991 | K912537 | JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION Thera Kinetics, Inc. | BXB |
| Aug 7, 1991 | K912086 | FMA TRANSLATOR Normandie Group, Inc. | BXB |
| Jun 28, 1991 | K904963 | EXTEND TRACK UNIT Anthony Chiropractic Clinic, Inc. | BXB |
| Feb 19, 1991 | K905718 | ROMFLEX Paraflex Corp. | BXB |
| Jan 30, 1991 | K904735 | DANNIFLEX MODEL 500TM CPM Buckman Co., Inc. | BXB |
| Jan 23, 1991 | K910150 | ROMFLEX REHAB EQUIP EXTREMITIES UNIT Dyna Flex, Intl. | BXB |
| Jan 18, 1991 | K910151 | ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT Dyna Flex, Intl. | BXB |
| Jan 18, 1991 | K910149 | ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT Dyna Flex, Intl. | BXB |
| Jan 18, 1991 | K910026 | ATI MEDICAL COMFORT PLUS CPM PAD Ati Medical, Inc. | BXB |
| Dec 31, 1990 | K905299 | ROMFLEX REHABILITATION EQUIPMENT Dyna Flex, Intl. | BXB |
| Nov 27, 1990 | K893924 | MOTO-MED RF-II AND PICO Holl Meditronics, Inc. | BXB |
| Oct 19, 1990 | K903851 | CLUB FOOT CPM MACHINE Smith & Nephew Richards, Inc. | BXB |
| Aug 10, 1990 | K903467 | JACE MODEL 100 KNEE CPM DEVICE Thera Kinetics, Inc. | BXB |
| Jul 25, 1990 | K902707 | MODEL 9000 AT ANKLE CPM DEVICE Sutter Corp. | BXB |
| Jun 11, 1990 | K902452 | CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER Berner Assoc., Inc. | BXB |
| Mar 12, 1990 | K900795 | MOBILIMB L4 LOWER LIMB CPM UNIT Toronto Medical Corp., CA | BXB |
| Mar 12, 1990 | K900466 | MOBILIMB W1 WRIST CPM UNIT Toronto Medical Corp., CA | BXB |
| Jan 4, 1990 | K895720 | MOBILIMB J1 TMJ CPM UNIT Toronto Medical Corp., CA | BXB |
| Oct 6, 1989 | K894907 | MARK IV HAND, THUMB AND WRIST (CPM) UNIT Innovative Medical Engineering, Inc. | BXB |
| Sep 11, 1989 | K895015 | ARTROMOT(TM) CPM DEVICES Buckman Co., Inc. | BXB |
| Apr 24, 1989 | K891345 | MOBILIMB CPM SHOULDER UNIT Toronto Medical Corp. | BXB |
| Mar 23, 1989 | K890838 | REHABOT-YM Imex Health, Inc. | BXB |
| Mar 15, 1989 | K885182 | TOTAL KNEE CPM Invacare Corp. | BXB |
| Feb 27, 1989 | K890607 | SUTTER HOSPITAL CPM Sutter Corp. | BXB |
| Feb 6, 1989 | K885095 | SUPREME TONING SYSTEMS Supreme Toning Systems | BXB |
| Feb 3, 1989 | K890200 | PNEUMATIC DORSIFLEXOR Medical Flotation Systems, Inc. | BXB |
| Jan 13, 1989 | K881314 | PROMO-RIST C.P.M. Professional Motion, Inc. | BXB |
| Nov 30, 1988 | K882406 | CONVA-LIFT Numerical Concepts, Inc. | BXB |
| Jul 28, 1988 | K882916 | MOTORIZED PARALLEL BAR, MODEL 110 Tri W-G, Inc. | BXB |
| May 2, 1988 | K880865 | RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 Invacare Corp. | BXB |
| Apr 21, 1988 | K873658 | ANKLE REFLEX TREATMENT UNIT (ARTU) Universal Gym Equipment, Inc. | BXB |
| Apr 11, 1988 | K880092 | RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 Invacare Corp. | BXB |
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