The following data is part of a premarket notification filed by Dalton Instrument Corp. with the FDA for Dalton Folding Wheelchairs.
| Device ID | K850178 |
| 510k Number | K850178 |
| Device Name: | DALTON FOLDING WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | DALTON INSTRUMENT CORP. 900 FRANCES WAY 214 Richardson, TX 75081 |
| Contact | Minji Lein |
| Correspondent | Minji Lein DALTON INSTRUMENT CORP. 900 FRANCES WAY 214 Richardson, TX 75081 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-17 |
| Decision Date | 1985-04-25 |