The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Modified Rotation Air Fluidized Bed/the Therapulse.
| Device ID | K875321 |
| 510k Number | K875321 |
| Device Name: | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Contact | A Wehrmeyer |
| Correspondent | A Wehrmeyer KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-01-27 |