The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Sidewinder Omni Wheelchair Direct/power.
| Device ID | K823175 |
| 510k Number | K823175 |
| Device Name: | SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER |
| Classification | Wheelchair, Powered |
| Applicant | KINETIC CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-26 |
| Decision Date | 1982-11-16 |