The following data is part of a premarket notification filed by Regulatory Insight, Inc. with the FDA for En 600-658, En 600-666, En 600-664, En 600-690, En 600-651, En 600-663, En 600-665 And En 600-670 Mechanical Wheelchairs.
| Device ID | K020094 |
| 510k Number | K020094 |
| Device Name: | EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 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 |