The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Modification To Mp-3 Power Base Chair.
Device ID | K993032 |
510k Number | K993032 |
Device Name: | MODIFICATION TO MP-3 POWER BASE CHAIR |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-10 |
Decision Date | 1999-11-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04714379292428 | K993032 | 000 |
04714379292411 | K993032 | 000 |
04714379292404 | K993032 | 000 |
04714379290844 | K993032 | 000 |
04714379290837 | K993032 | 000 |
04714379290820 | K993032 | 000 |
04714379290813 | K993032 | 000 |
04714379290806 | K993032 | 000 |