510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923396Substantially Equivalent

Thermodyn

Nemectron Medical, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923396 is the FDA 510(k) clearance record for THERMODYN, a class II device, cleared for Nemectron Medical, Inc. on under FDA product code IRT (Pad, Heating, Powered). FDA records list 13 510(k) clearances for Nemectron Medical, Inc., from to . As of , FDA records show no recalls naming K923396.

Clearance record

Decision date
Received
(320 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Nemectron Medical, Inc. 28069 Diaz Rd. Unit A, Temecula CA
510(k) summary
Statement
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

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