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
K771030Substantially Equivalent

Flexion Mittens

Stat Medical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771030 is the FDA 510(k) clearance record for FLEXION MITTENS, a class I device, cleared for Stat Medical Corp. on under FDA product code IOD (Components, Exercise). FDA records list 4 510(k) clearances for Stat Medical Corp., from to . As of , FDA records show no recalls naming K771030.

Clearance record

Decision date
Received
(18 days to decision)
Product code
IOD Components, Exercise
Regulation
21 CFR 890.5350
Device class
Class I
Review panel
Physical Medicine
Applicant
Stat Medical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IOD

Trailing 12 months

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

FDA records show no clearances under product code IOD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOD, 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