The following data is part of a premarket notification filed by Dignity Medical Devices, Inc with the FDA for Dignity 100.
| Device ID | K082246 |
| 510k Number | K082246 |
| Device Name: | DIGNITY 100 |
| Classification | Wheelchair, Mechanical |
| Applicant | DIGNITY MEDICAL DEVICES, INC 16917 73RD PLACE N Maple Grove, MN 55311 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton DIGNITY MEDICAL DEVICES, INC 16917 73RD PLACE N Maple Grove, MN 55311 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-09-09 |
| Summary: | summary |