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
K790527Substantially Equivalent

Burnett-Ketchum Dynamic Hand Exerciser

Maddak, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790527 is the FDA 510(k) clearance record for BURNETT-KETCHUM DYNAMIC HAND EXERCISER, a class I device, cleared for Maddak, Inc. on under FDA product code JFA (Exerciser, Finger, Powered). FDA records list 51 510(k) clearances for Maddak, Inc., from to . As of , FDA records show no recalls naming K790527.

Clearance record

Decision date
Received
(7 days to decision)
Product code
JFA Exerciser, Finger, Powered
Regulation
21 CFR 890.5410
Device class
Class I
Review panel
Physical Medicine
Applicant
Maddak, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JFA

Trailing 12 months

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

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