The following data is part of a premarket notification filed by Dalton Medical Corp. with the FDA for Primechair.
| Device ID | K021199 |
| 510k Number | K021199 |
| Device Name: | PRIMECHAIR |
| Classification | Wheelchair, Powered |
| Applicant | DALTON MEDICAL CORP. 1103 VENTURE CT. Carrollton, TX 75006 |
| Contact | Will Ridgway |
| Correspondent | Will Ridgway DALTON MEDICAL CORP. 1103 VENTURE CT. Carrollton, TX 75006 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-16 |
| Decision Date | 2002-07-12 |