The following data is part of a premarket notification filed by Plainsense Wheelchairs, Inc. with the FDA for Plainsense Wheelchair.
| Device ID | K001909 |
| 510k Number | K001909 |
| Device Name: | PLAINSENSE WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | PLAINSENSE WHEELCHAIRS, INC. 2919 BENTWOOD DR. Marietta, GA 30062 -4608 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-08-25 |