The following data is part of a premarket notification filed by Wardray Premise Ltd with the FDA for Mr4500 Wheelchair.
| Device ID | K120391 |
| 510k Number | K120391 |
| Device Name: | MR4500 WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | WARDRAY PREMISE LTD 7 VILLAGE WOODS DR Amherst, NH 03031 |
| Contact | James Wason Ph.d. |
| Correspondent | James Wason Ph.d. WARDRAY PREMISE LTD 7 VILLAGE WOODS DR Amherst, NH 03031 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-12-21 |
| Summary: | summary |