510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010380Substantially Equivalent

Mp3hd Big Boy, Power Wheelchair

Merits Health Products, Inc., Cape Coral FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K010380 is the FDA 510(k) clearance record for MP3HD BIG BOY, POWER WHEELCHAIR, a class II device, cleared for Merits Health Products., Inc. on under FDA product code ITI (Wheelchair, Powered). FDA's definition for product code ITI reads: "A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to...". FDA records list 31 510(k) clearances for Merits Health Products., Inc., from to . As of , FDA records show no recalls naming K010380.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
Device class
Class II
Review panel
Physical Medicine
Applicant
Merits Health Products., Inc. P.O.Box 150356, Cape Coral FL
510(k) summary
Statement
Third party review
No

Clearances, product code ITI

Trailing 12 months
36 clearances under product code ITI in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code ITI, trailing twelve months
MonthClearances
November 20253
December 20253
January 20262
February 20263
March 20267
April 20263
May 20261
June 20266
July 20263
August 20261
September 20264
October 20260