The following data is part of a premarket notification filed by Next Wave, Inc. with the FDA for Next Wave(r) Physioaccoustic(tm) Chair.
| Device ID | K905256 |
| 510k Number | K905256 |
| Device Name: | NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | NEXT WAVE, INC. 5555 GULL ROAD, SUITE 103 Kalamazoo, MI 49001 |
| Contact | Harmon H Woodworth |
| Correspondent | Harmon H Woodworth NEXT WAVE, INC. 5555 GULL ROAD, SUITE 103 Kalamazoo, MI 49001 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-21 |
| Decision Date | 1991-03-12 |