The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Orthoderm Consummate Air Therapy Bed W/scale.
| Device ID | K926189 |
| 510k Number | K926189 |
| Device Name: | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Contact | Greg Godfrey |
| Correspondent | Greg Godfrey BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1993-06-24 |