The following data is part of a premarket notification filed by Next Wave, Inc. with the FDA for Next Wave Physioacoustic Mattress.
| Device ID | K934886 |
| 510k Number | K934886 |
| Device Name: | NEXT WAVE PHYSIOACOUSTIC MATTRESS |
| Classification | Vibrator, Therapeutic |
| Applicant | NEXT WAVE, INC. 5555 GULL ROAD, SUITE 103 Kalamazoo, MI 49001 |
| Contact | Roland H Potrykus |
| Correspondent | Roland H Potrykus NEXT WAVE, INC. 5555 GULL ROAD, SUITE 103 Kalamazoo, MI 49001 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-06-09 |