510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021866Substantially Equivalent

Karma 800 Series Manual Wheelchair

Vestil Manufacturing Corp., Angola IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021866 is the FDA 510(k) clearance record for KARMA 800 SERIES MANUAL WHEELCHAIR, a class I device, cleared for Vestil Manufacturing 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 6 510(k) clearances for Vestil Manufacturing Corp., from to . As of , FDA records show no recalls naming K021866.

Clearance record

Decision date
Received
(8 days to decision)
Product code
IOR Wheelchair, Mechanical
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Vestil Manufacturing Corp. 900 Growth Pkwy., Angola IN
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