510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915629Substantially Equivalent

Cushion, Whelchar and Flotation

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915629 is the FDA 510(k) clearance record for CUSHION, WHELCHAR AND FLOTATION, a class I device, cleared for Invacare Corp. on under FDA product code KNN (Components, Wheelchair). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K915629.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KNN Components, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Invacare Corp. 899 Cleveland St., Elyria OH
510(k) summary
Summary
Third party review
No

Clearances, product code KNN

Trailing 12 months

FDA records hold no clearances under product code KNN in the trailing twelve months.

FDA records show no clearances under product code KNN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260