The following data is part of a premarket notification filed by Tuffman Industries with the FDA for Tuffcare Medical Products Wheelchair.
| Device ID | K894422 |
| 510k Number | K894422 |
| Device Name: | TUFFCARE MEDICAL PRODUCTS WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | TUFFMAN INDUSTRIES 3558 EAST ENT. DR. Anaheim, CA 92807 |
| Contact | Calvin Chang |
| Correspondent | Calvin Chang TUFFMAN INDUSTRIES 3558 EAST ENT. DR. Anaheim, CA 92807 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-08-03 |