The following data is part of a premarket notification filed by Daun International, Inc. with the FDA for Meriuaara & Eracare Wheelchairs.
| Device ID | K851553 |
| 510k Number | K851553 |
| Device Name: | MERIUAARA & ERACARE WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
| Contact | Glenn Z Hering |
| Correspondent | Glenn Z Hering DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-07-09 |