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 21, 1983 | K823495 | MOBILIMB-CPM UPPER/LOWER LIMB DEVICE Synthes (Usa) | BXB |
| Jan 14, 1983 | K823539 | SUTTER CPM Sutter Biomedical, Inc. | BXB |
| Aug 31, 1982 | K822212 | MOTORIZED EXERCISER W.R. Mccullin | BXB |
| Jul 26, 1982 | K822031 | AUTORANGE MODEL 205 Tri W-G, Inc. | BXB |
| Apr 26, 1982 | K821016 | QUADRUPLE JOGGER EXERCISER Industrial Energy Specialists, Inc. | BXB |
| Mar 8, 1982 | K820476 | KEM-2 Medical Graphics Corp. | BXB |
| Jan 29, 1982 | K820120 | PATIENT GUIDED KNEE EXERCISER Richard'S Medical Equip., Inc. | BXB |
| Jan 28, 1982 | K820083 | SUTTER CPM Sutter Biomedical, Inc. | BXB |
| Feb 13, 1981 | K810238 | SUPINE STRESS SYSTEM O'Neill | BXB |
| Jan 21, 1980 | K800007 | WORK SIMULATOR Baltimore Therapeutic Equipment Co. | BXB |
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