Stimulator, Neuromuscular, External Functional
Regulation 882.5810
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 GZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioness, Inc. | 9 | 0 |
| Restorative Therapies, Inc. | 9 | 0 |
| Ness-Neuromuscular Electrical Stimulation Systems | 5 | 0 |
| Hasomed GmbH | 4 | 0 |
| Innovative Neurotronics, Inc. | 3 | 1 |
| Cionic | 3 | 0 |
| Myndtec, Inc. | 3 | 0 |
| Myolyn, LLC | 2 | 1 |
| Odstock Medical, Ltd. | 2 | 0 |
| Shenzhen Xft Medical Limited | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2022 | Myolyn Inc. Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Terminated |
GZI | K213925 |
| Jun 3, 2009 | Innovative Neurotronics, Inc. WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746.
The WalkAide is a battery opera Terminated |
GZI | K052329 |
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