510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K954427Substantially Equivalent

Helping Hand

Kinetic Rehabilitation Instruments, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954427 is the FDA 510(k) clearance record for HELPING HAND, a class II device, cleared for Kinetic Rehabilitation Instruments, 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 one 510(k) clearance for Kinetic Rehabilitation Instruments, Inc. As of , FDA records show no recalls naming K954427.

Clearance record

Decision date
Received
(360 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
Device class
Class II
Review panel
Physical Medicine
Applicant
Kinetic Rehabilitation Instruments, Inc. 601 13th St. NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code ITI

Trailing 12 months
39 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 20265
October 20262