The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for H Wave Muscle Stimulator.
| Device ID | K915230 |
| 510k Number | K915230 |
| Device Name: | H WAVE MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Contact | Jim Heaney |
| Correspondent | Jim Heaney ELECTRONIC WAVEFORM LABORATORY, INC. 15683 CHEMICAL LN. Huntington Beach, CA 92649 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1992-05-08 |