The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Bio Therapy (tm) Advanced Pressure Relief System.
| Device ID | K883256 |
| 510k Number | K883256 |
| Device Name: | BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | BIO CLINIC CO. ATTORNEY AT LAW 2085 RUSTIN AVENUE Riverside, CA 92507 |
| Contact | Stanley E Fry |
| Correspondent | Stanley E Fry BIO CLINIC CO. ATTORNEY AT LAW 2085 RUSTIN AVENUE Riverside, CA 92507 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-02 |
| Decision Date | 1988-10-31 |