The following data is part of a premarket notification filed by Amg Medical Inc. with the FDA for Urok Rocking Wheelchair, Model 700-4xx.
| Device ID | K052548 |
| 510k Number | K052548 |
| Device Name: | UROK ROCKING WHEELCHAIR, MODEL 700-4XX |
| Classification | Wheelchair, Mechanical |
| Applicant | AMG MEDICAL INC. 8505 DALTON Montreal, Quebec, CA H4t 1v5 |
| Contact | Kenneth Levesque |
| Correspondent | Kenneth Levesque AMG MEDICAL INC. 8505 DALTON Montreal, Quebec, CA H4t 1v5 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2006-01-06 |
| Summary: | summary |