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
K941567Substantially Equivalent

Diathermy Device-Microfocus

Cheung Laboratories, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941567 is the FDA 510(k) clearance record for DIATHERMY DEVICE-MICROFOCUS, a class II device, cleared for Cheung Laboratories, Inc. on under FDA product code IOA (Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Cheung Laboratories, Inc. As of , FDA records show no recalls naming K941567.

Clearance record

Decision date
Received
(752 days to decision)
Product code
IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5275
Device class
Class II
Review panel
Physical Medicine
Applicant
Cheung Laboratories, Inc. 10220-I Old Columbia Rd., Columbia MD
510(k) summary
Statement
Third party review
No

Clearances, product code IOA

Trailing 12 months

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

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