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510(k) Premarket Notification
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| Device Classification Name |
Stimulator, Nerve, Transcutaneous, for Pain Relief |
| 510(k) Number |
K896948 |
| Regulation Number |
882.5890 |
| Device Name |
ALPHA-STIM CS |
| Applicant |
ELECTROMEDICAL PRODUCTS, INC |
| Contact |
L Kirsch |
| Classification Product Code |
GZJ |
| Date Received |
12/13/1989 |
| Decision Date |
02/23/1990 |
| Decision |
Substantially equivalent (SE) |
| Classification Advisory Committee |
Neurology |
| Review Advisory Committee |
Neurology |
| Statement/Summary/Purged Status |
Purged, no summary or statement |
| Type |
Traditional |
| Reviewed by Third Party |
No |
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