Panels › Physical Medicine › Product code ION · Class 1
Exerciser, Non-Measuring
Regulation 890.5370
0510(k)s in 12 months (43 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in ION
| Company | 510(k)s | Recalls |
|---|---|---|
| Fred Sammons, Inc. | 18 | 0 |
| Maddak, Inc. | 7 | 0 |
| Hosmer Dorrance Corp. | 2 | 0 |
| Lossing Orthopedic, Inc. | 2 | 0 |
| Alt, Inc. | 1 | 0 |
| Amtryke LLC | 0 | 1 |
| Back Rite | 1 | 0 |
| Fitness Equipment Co., Inc. | 1 | 0 |
| I-Rep, Inc. | 1 | 0 |
| Im-Able, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2015 | Amtryke LLC AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. Terminated |
ION | None listed |
| May 14, 2012 | North Coast Medical Inc Norco Shoulder Pulley
Distributed by North Coast Medical, Gilroy, CA.
Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery. Terminated |
ION | None listed |
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