The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Com-tens: A Neurostimulator.
| Device ID | K902102 |
| 510k Number | K902102 |
| Device Name: | COM-TENS: A NEUROSTIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | APEX MEDICAL, INC. P.O. DRAWER 179 Pen Valley, CA 95946 |
| Contact | Thomas Daigle |
| Correspondent | Thomas Daigle APEX MEDICAL, INC. P.O. DRAWER 179 Pen Valley, CA 95946 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-08 |
| Decision Date | 1991-05-30 |