The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Bio Therapy Plus.
| Device ID | K922205 |
| 510k Number | K922205 |
| Device Name: | BIO THERAPY PLUS |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | SUNRISE MEDICAL, INC. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Contact | Greg Godfrey |
| Correspondent | Greg Godfrey SUNRISE MEDICAL, INC. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-12 |
| Decision Date | 1992-08-11 |