The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Roto Rest Kinetic Treatment Table Pedia.
| Device ID | K822402 |
| 510k Number | K822402 |
| Device Name: | ROTO REST KINETIC TREATMENT TABLE PEDIA |
| Classification | Bed, Patient Rotation, Powered |
| Applicant | KINETIC CONCEPTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-10 |
| Decision Date | 1982-10-22 |