510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K032449Substantially Equivalent

Thermassage Energy Product, Model Hy5000

Migun Medical Instrument Co., Ltd., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032449 is the FDA 510(k) clearance record for THERMASSAGE ENERGY PRODUCT, MODEL HY5000, a class II device, cleared for Migun Medical Instrument Co. , Ltd. on under FDA product code JFB (Table, Physical Therapy, Multi Function). FDA records list 2 510(k) clearances for Migun Medical Instrument Co. , Ltd., from to . As of , FDA records show no recalls naming K032449.

Clearance record

Decision date
Received
(75 days to decision)
Product code
JFB Table, Physical Therapy, Multi Function
Regulation
21 CFR 890.5880
Device class
Class II
Review panel
Physical Medicine
Applicant
Migun Medical Instrument Co. , Ltd. 5905 Fawn Ln., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JFB

Trailing 12 months

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

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