The following data is part of a premarket notification filed by R82 A/s with the FDA for Cougar Wheelchair.
| Device ID | K061810 |
| 510k Number | K061810 |
| Device Name: | COUGAR 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 | 2006-06-27 |
| Decision Date | 2006-08-07 |