Panels › Physical Medicine › Product code ISD · Class 2
Exerciser, Measuring
Regulation 890.5360
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in ISD
| Company | 510(k)s | Recalls |
|---|---|---|
| Henley Intl. | 4 | 0 |
| Quinton, Inc. | 4 | 0 |
| Tri-Tech, Inc. | 4 | 0 |
| Biodan Medical Systems, Ltd. | 3 | 0 |
| Stanford Scientific, Inc. | 3 | 0 |
| Battle Creek Equipment Co. | 2 | 0 |
| Engineering Dynamics Corp. | 2 | 0 |
| Ergoline GmbH | 2 | 0 |
| Lode B.V. | 2 | 0 |
| Penny and Giles Biometrics , Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2015 | BTE Technologies, Inc. Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation t Terminated |
ISD | K933611 |
| Jan 7, 2015 | MedX Holdings, Inc. Lumbar Extension Machine
for Physical Therapy Terminated |
ISD | K880032 |
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