The following data is part of a premarket notification filed by Major Mobility Products, Inc. with the FDA for Manual Wheelchair.
| Device ID | K994185 |
| 510k Number | K994185 |
| Device Name: | MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | MAJOR MOBILITY PRODUCTS, INC. 18206 MANCE CT. Houston, TX 77094 |
| Contact | Scott Schweiss |
| Correspondent | Scott Schweiss MAJOR MOBILITY PRODUCTS, INC. 18206 MANCE CT. Houston, TX 77094 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-10 |
| Decision Date | 2000-01-13 |