The following data is part of a premarket notification filed by Nova Ortho-med, Inc. with the FDA for 7000 Series Lightweight Wheelchair, Models 7160l, 7180l And 7200l.
| Device ID | K061273 |
| 510k Number | K061273 |
| Device Name: | 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L |
| Classification | Wheelchair, Mechanical |
| Applicant | NOVA ORTHO-MED, INC. 345 WEST VICTORIA ST. Gardena, CA 90248 |
| Contact | Sue Chen |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-05-23 |
| Summary: | summary |