The following data is part of a premarket notification filed by Dalton Instrument Corp. with the FDA for Relay Power Wheelchair.
| Device ID | K101611 |
| 510k Number | K101611 |
| Device Name: | RELAY POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | DALTON INSTRUMENT CORP. 3788 ARAPAHO RD Addiison, TX 75001 |
| Contact | Jennifer Yu |
| Correspondent | Jennifer Yu DALTON INSTRUMENT CORP. 3788 ARAPAHO RD Addiison, TX 75001 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-09-29 |
| Summary: | summary |