The following data is part of a premarket notification filed by Karman Healthcare, Inc. with the FDA for Karma Wheelchair.
| Device ID | K950195 |
| 510k Number | K950195 |
| Device Name: | KARMA WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | KARMAN HEALTHCARE, INC. 9662 EAST RUSH ST. South El Monte, CA 91733 |
| Contact | Alex C Horng |
| Correspondent | Alex C Horng KARMAN HEALTHCARE, INC. 9662 EAST RUSH ST. South El Monte, CA 91733 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-03-07 |