510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900355Substantially Equivalent

Mark VII Thermoregulation Assist System

Life Enhancement Technologies, LLC, Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900355 is the FDA 510(k) clearance record for MARK VII THERMOREGULATION ASSIST SYSTEM, a class II device, cleared for Life Enhancement Technologies, LLC on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 3 510(k) clearances for Life Enhancement Technologies, LLC, from to . As of , FDA records show no recalls naming K900355.

Clearance record

Decision date
Received
(21 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Life Enhancement Technologies, LLC Medical & Radiation Technology, Bethesda MD
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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