The following data is part of a premarket notification filed by Regulatory Insight, Inc. with the FDA for Sl 803, Sl 804, Sl 807, Sl 809, Sl 506, Sl 501, Sl 805 And Sl 801 Mechanical Wheelchairs.
| Device ID | K020100 |
| 510k Number | K020100 |
| Device Name: | SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | REGULATORY INSIGHT, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 13 RED FOX LN. Littleton, CO 80127 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-11 |
| Decision Date | 2002-03-08 |