510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915876Substantially Equivalent

Hotpad

Ten Comfort Corp., Taiwan R.O.C., CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915876 is the FDA 510(k) clearance record for HOTPAD, a class I device, cleared for Ten Comfort Corp. on under FDA product code IME (Pack, Hot Or Cold, Reusable). FDA records list one 510(k) clearance for Ten Comfort Corp. As of , FDA records show no recalls naming K915876.

Clearance record

Decision date
Received
(421 days to decision)
Product code
IME Pack, Hot Or Cold, Reusable
Regulation
21 CFR 890.5700
Device class
Class I
Review panel
Physical Medicine
Applicant
Ten Comfort Corp. P.O. Box 577 Yung-Ho, Taiwan R.O.C., CN
510(k) summary
Statement
Third party review
No

Clearances, product code IME

Trailing 12 months

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

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