The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for E.w.l. P-tens/h-wave.
| Device ID | K862121 |
| 510k Number | K862121 |
| Device Name: | E.W.L. P-TENS/H-WAVE |
| Classification | Device, Muscle Monitoring |
| Applicant | ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Contact | W. J Heaney |
| Correspondent | W. J Heaney ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1987-06-17 |