FDA.report

SHARPER IMAGE

Primary DI
06973305010255
Brand
SHARPER IMAGE
Company
Zhejiang Lumeng Health & Technology Co., Ltd.
Model
CHKW-5
Catalog number
CWT16003/31689
Device description
CALMING HEAT KNEE WRAP
Published
2022-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IRTPad, Heating, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16973305010252PackageGS13In Commercial Distribution
06973305010255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697330501025216973305010252
06973305010255069733050102556973305010255

GMDN Terms

TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods

Method

Contacts

PhoneEmail
914 593-6670chenchenl@allstarmg.com

Regulatory Flags

DUNS number
421341654
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06973305010217SHARPER IMAGECH2-6CWT47012/CWT02106/CWT05112/31424A/31580/CWT340062022-05-03
06973305010224SHARPER IMAGECH2-9CWT48012/CWT03106/315792022-05-03
06973305010231SHARPER IMAGECHC-3CCZ010042022-05-03
06973305010248SHARPER IMAGECHNW-3CWT180042022-05-03
06973305010262SHARPER IMAGECH2-9LCWT04106/CWT32003/31456/315812022-05-03
06973305010279SHARPER IMAGECHJ-9315782022-05-03
06973305010286Calming Heat Sauna WrapCHSW-3CWT42001/317832022-05-03
06973305010071SHARPER IMAGE315802020-11-03
06973305010088SHARPER IMAGE315792020-11-03
06973305010095SHARPER IMAGE315812020-11-03
06973305010200All star316902021-12-30
06973305010194All star7716442021-09-30
06973305010187All star316952021-06-23
06973305010156All starCWT180042021-04-30
06973305010163All star316332021-04-30
06973305010170All starCWT170032021-04-30
06973305010118All star315822021-04-12
06973305010149All star315832021-04-12
06973305010101SHARPER IMAGECWT120062020-12-22
06973305010125SHARPER IMAGE315842020-12-22

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