MP3HD BIG BOY, POWER WHEELCHAIR

Wheelchair, Powered

MERITS HEALTH PRODUCTS., INC.

The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Mp3hd Big Boy, Power Wheelchair.

Pre-market Notification Details

• Device ID: K010380
• 510k Number: K010380
• Device Name: MP3HD BIG BOY, POWER 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: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-08
• Decision Date: 2001-05-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04714379291025	K010380	000
04714379291018	K010380	000
04714379292510	K010380	000
04714379292503	K010380	000