510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111636Substantially Equivalent

Rehab Tnt, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab Tnt and Rehab Ram

GUNNELL, Inc., Millington MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111636 is the FDA 510(k) clearance record for REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM, a class I device, cleared for Gunnell, Inc. on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually 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”...". FDA records list one 510(k) clearance for Gunnell, Inc. As of , FDA records show one recall naming K111636.

Clearance record

Decision date
Received
(295 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Gunnell, Inc. 8440 State, Millington MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IOR

Trailing 12 months
21 clearances under product code IOR in the twelve months to October 2026, September 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code IOR, trailing twelve months
MonthClearances
November 20252
December 20252
January 20262
February 20260
March 20261
April 20261
May 20262
June 20264
July 20261
August 20261
September 20265
October 20260