Home GUDID B9301610000 Welkins
Primary DI B9301610000
Brand Welkins
Company WELKINS, LLC
Model TRS-2
Catalog number 161000
Device description Temperature Management System
Published 2021-03-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name DWJ System, Thermal Regulating
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWJ System, Thermal Regulating Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B9301610000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Circulating-fluid thermal therapy system An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings.
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