FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DWJSystem, Thermal Regulating

Product Code Classifications

CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions

SubmissionSupplement
K121720000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K121720000WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEMWelkins, LLC2012-08-20DWJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B9301610000PrimaryHIBCC0

GMDN Terms

TermDefinition
Circulating-fluid thermal therapy systemAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
2074496398christopher@welkinsmed.com

Regulatory Flags

DUNS number
961818320
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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