The following data is part of a premarket notification filed by Rgk Wheelchairs, Ltd. with the FDA for Rgk Daily Range Wheelchairs.
| Device ID | K200135 |
| 510k Number | K200135 |
| Device Name: | RGK Daily Range Wheelchairs |
| Classification | Wheelchair, Mechanical |
| Applicant | RGK Wheelchairs, Ltd. Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood, GB Ws7 3jq |
| Contact | Devin Mcelroy |
| Correspondent | Devin Mcelroy RGK Wheelchairs, Ltd. Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood, GB Ws7 3jq |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00016958060249 | K200135 | 000 |
| 00016958059373 | K200135 | 000 |
| 00016958057591 | K200135 | 000 |
| 50567627060244 | K200135 | 000 |
| 50567627059378 | K200135 | 000 |
| 50567627057596 | K200135 | 000 |