The following data is part of a premarket notification filed by Redman, Inc. with the FDA for Red Pack Manlual Power Wheelchair Conversion Kit.
Device ID | K940851 |
510k Number | K940851 |
Device Name: | RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT |
Classification | Wheelchair, Powered |
Applicant | REDMAN, INC. 945 EAST OHIO, SUITE #4 Tucson, AZ 85714 |
Contact | Don Redman |
Correspondent | Don Redman REDMAN, INC. 945 EAST OHIO, SUITE #4 Tucson, AZ 85714 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-23 |
Decision Date | 1995-02-03 |