The following data is part of a premarket notification filed by R82 A/s with the FDA for Multi Frame Wheelchair.
| Device ID | K100084 |
| 510k Number | K100084 |
| Device Name: | MULTI FRAME WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | R82 A/S 12801 EAST INDEPENDENCE BLVD. Stallings, NC 28105 |
| Contact | Kirk Mackenzie |
| Correspondent | Kirk Mackenzie R82 A/S 12801 EAST INDEPENDENCE BLVD. Stallings, NC 28105 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05707292607850 | K100084 | 000 |
| 05707292561831 | K100084 | 000 |
| 05707292561848 | K100084 | 000 |
| 05707292565006 | K100084 | 000 |
| 05707292565617 | K100084 | 000 |
| 05707292565716 | K100084 | 000 |
| 05707292566232 | K100084 | 000 |
| 05707292567079 | K100084 | 000 |
| 05707292569073 | K100084 | 000 |
| 05707292571793 | K100084 | 000 |
| 05707292573582 | K100084 | 000 |
| 05707292576279 | K100084 | 000 |
| 05707292591999 | K100084 | 000 |
| 05707292561817 | K100084 | 000 |