The following data is part of a premarket notification filed by Redman, Inc. with the FDA for Dakota Model 102c Wheelchair.
Device ID | K870297 |
510k Number | K870297 |
Device Name: | DAKOTA MODEL 102C WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | REDMAN, INC. 9340 COLORADO AVE. Bloomington, MN 55438 |
Contact | Michael R Miller |
Correspondent | Michael R Miller REDMAN, INC. 9340 COLORADO AVE. Bloomington, MN 55438 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-02-10 |