510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082857Substantially Equivalent

Renegade Wheelchair

Alpha One, Chevy Chase MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082857 is the FDA 510(k) clearance record for RENEGADE WHEELCHAIR, a class II device, cleared for Alpha One on under FDA product code IQC (Wheelchair, Special Grade). FDA records list one 510(k) clearance for Alpha One. As of , FDA records show no recalls naming K082857.

Clearance record

Decision date
Received
(99 days to decision)
Product code
IQC Wheelchair, Special Grade
Regulation
21 CFR 890.3880
Device class
Class II
Review panel
Physical Medicine
Applicant
Alpha One 5600 Wisconsin Ave., Chevy Chase MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IQC

Trailing 12 months

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

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