Medical Device
Manufacturing
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K941088Substantially Equivalent

Stryker Back-Saver Stretcher Chair Model 6320

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent

K941088 is the FDA 510(k) clearance record for STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320, a class I device, cleared for Stryker Corp. 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 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K941088.

Clearance record

Decision date
Received
(38 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Stryker Corp. Medical Div., Kalamazoo MI
510(k) summary
Statement
Third party review
No

Clearances, product code IOR

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