The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Mp3cf Electric Wheelchair.
Device ID | K012802 |
510k Number | K012802 |
Device Name: | MP3CF ELECTRIC WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
Contact | Winston Anderson |
Correspondent | Winston Anderson MERITS HEALTH PRODUCTS., INC. P.O. BOX 150356 Cape Coral, FL 33915 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-21 |
Decision Date | 2001-09-18 |