510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944885Substantially Equivalent for Some Indications

Dh-1, Dh-2, Dh-3, Dh-6, Dh-68, Dh-8, Amh-6, Fm-10, Fm-20, Fm-30, Fbm-1000, Fbm-2000

Kolvin Industries, Ltd., Kowloon, HK / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K944885 is the FDA 510(k) clearance record for DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000, a class I device, cleared for Kolvin Industries , Ltd. on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 2 510(k) clearances for Kolvin Industries , Ltd. As of , FDA records show no recalls naming K944885.

Clearance record

Decision date
Received
(134 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Kolvin Industries , Ltd. Unit 6,M/F.,Century Centre,, Kowloon, HK
Third party review
No

Clearances, product code ISA

Trailing 12 months

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

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