Thermoaire Splint (TAS)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Thermoaire Splint (Tm) (Tas)

510(k) Number

K900356 ↗

FDA Product Code

ILO

Device Class

Class II

Regulation

21 CFR Part 890.5720

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Mark VII Thermoregulation Assist System

  Class II

  FDA 510(k) K900355 Active Cleared 15 Feb 1990

• Karlson Ozone Sterilizer Model 100B

  Class II

  FDA 510(k) K873200 Active Cleared 27 Jan 1989

• What is the Thermoaire Splint (TAS) used for?

  The Thermoaire Splint (TAS) is a hot or cold water circulating pack designed for physical medicine applications to provide therapeutic temperature management for various medical conditions.

• How is the Thermoaire Splint supplied and what sizes are available?

  The device is supplied as a Class II medical device and is available in various sizes as indicated by the model numbers listed in the device data. The specific model numbers would need to be referenced from the manufacturer's documentation.

• What is the regulatory status of the Thermoaire Splint?

  The Thermoaire Splint has FDA 510(k) clearance K900356 with product code ILO and regulation number 890.5720. It is manufactured by Life Enhancement Technologies, LLC and is classified as a Class II medical device.

• Is the Thermoaire Splint single-use or reusable?

  The device data does not specify whether the Thermoaire Splint is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer's instructions for use or product documentation.