510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040031Substantially Equivalent

Ceragem-C Thermal Acupressure Massager

Ceragem Co., Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040031 is the FDA 510(k) clearance record for CERAGEM-C THERMAL ACUPRESSURE MASSAGER, a class II device, cleared for Ceragem Co., Ltd. on under FDA product code JFB (Table, Physical Therapy, Multi Function). FDA records list 7 510(k) clearances for Ceragem Co., Ltd., from to . As of , FDA records show no recalls naming K040031.

Clearance record

Decision date
Received
(202 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
Ceragem Co., Ltd. 1800 Massachusetts Ave. NW, Washington DC
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