The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Bio Medx Air Flotation System.
| Device ID | K905156 |
| 510k Number | K905156 |
| Device Name: | BIO MEDX AIR FLOTATION SYSTEM |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Contact | Keith Gilroy |
| Correspondent | Keith Gilroy 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 | 1990-11-15 |
| Decision Date | 1990-11-27 |