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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2001 | K010837 | HANDMASTER Neuromusclar Electrical Stimulation Systems, Ltd. | GZI |
| Feb 6, 1998 | K974514 | EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR Neuromotion, Inc., CA | GZI |
| Mar 16, 1995 | K940759 | FORTE ES Chattanooga Group, Inc. | GZI |
| Feb 7, 1992 | K911066 | COMFORTRON PT (TENS) M. D. Supply, Inc. | GZI |
| Sep 27, 1991 | K912615 | ROCHE COBAS ARGOS 5 DIFF Roche Diagnostic Systems, Inc. | GZI |
| Aug 9, 1991 | K903434 | SELECT NEUROMUSCULAR STIMULATORS Medtronic Vascular | GZI |
| Sep 30, 1987 | K873608 | TENS LEAD Desco Industries, Inc. | GZI |
| Jan 19, 1982 | K813515 | VERI/DFS TM #817 Verite | GZI |
| Mar 17, 1980 | K800380 | FES ORTHOSIS MODEL NO. 2000 Empi | GZI |
| Jun 14, 1977 | K770987 | NERVE STIMULATOR, MOLEL NO. FB-800 Output, Inc. | GZI |
| Apr 26, 1977 | K770725 | STIMULATOR, MUSCLE, MODEL 107 Jaytronics, Inc. | GZI |
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