The following data is part of a premarket notification filed by Dalton Medical Corp. with the FDA for Primechair.
| Device ID | K052496 |
| 510k Number | K052496 |
| 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 | 2005-09-12 |
| Decision Date | 2005-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815027011744 | K052496 | 000 |
| 00815027011683 | K052496 | 000 |
| 00815027011676 | K052496 | 000 |
| 00815027011669 | K052496 | 000 |
| 00815027011652 | K052496 | 000 |
| 00815027011621 | K052496 | 000 |
| 00815027011447 | K052496 | 000 |