The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for H-wave Sport.
| Device ID | K081998 |
| 510k Number | K081998 |
| Device Name: | H-WAVE SPORT |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | ELECTRONIC WAVEFORM LABORATORY, INC. 16168 BEACH BLVD., SUITE 232 Huntington Beach, CA 92647 |
| Contact | Ryan P Heaney |
| Correspondent | Ryan P Heaney ELECTRONIC WAVEFORM LABORATORY, INC. 16168 BEACH BLVD., SUITE 232 Huntington Beach, CA 92647 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2009-07-09 |
| Summary: | summary |