The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Modified Pedikair.
| Device ID | K954320 |
| 510k Number | K954320 |
| Device Name: | MODIFIED PEDIKAIR |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Contact | William H Quirk |
| Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-07 |
| Decision Date | 1997-07-18 |
| Summary: | summary |