The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for E.w.l. P-tens Model(tens.
| Device ID | K813601 |
| 510k Number | K813601 |
| Device Name: | E.W.L. P-TENS MODEL(TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ELECTRONIC WAVEFORM LABORATORY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-28 |
| Decision Date | 1982-03-19 |