The following data is part of a premarket notification filed by Sigma Distribution & Supply, Inc. with the FDA for Sigma Manual Wheelchair.
| Device ID | K993963 |
| 510k Number | K993963 |
| Device Name: | SIGMA MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | SIGMA DISTRIBUTION & SUPPLY, INC. 701 WEST HARVARD ST. Glendale, CA 91204 |
| Contact | Arthur Keshishyan |
| Correspondent | Arthur Keshishyan SIGMA DISTRIBUTION & SUPPLY, INC. 701 WEST HARVARD ST. Glendale, CA 91204 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 2000-01-13 |