FDA.reportPublic FDA data

SHARPER IMAGE

Primary DI
06973305010279
Brand
SHARPER IMAGE
Company
Zhejiang Lumeng Health & Technology Co., Ltd.
Model
CHJ-9
Catalog number
31578
Device description
MASSAGING WEIGHTED HEATING PAD WITH JADE STONES
Published
2022-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973305010279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973305010279069733050102796973305010279

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
914 593-6670chenchenl@allstarmg.com

Regulatory Flags#

DUNS number
421341654
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973305010224SHARPER IMAGECH2-9CWT48012/CWT03106/315792022-05-03
06973305010255SHARPER IMAGECHKW-5CWT16003/316892022-05-03
06973305010262SHARPER IMAGECH2-9LCWT04106/CWT32003/31456/315812022-05-03
06973305010217SHARPER IMAGECH2-6CWT47012/CWT02106/CWT05112/31424A/31580/CWT340062022-05-03
06973305010231SHARPER IMAGECHC-3CCZ010042022-05-03
06973305010248SHARPER IMAGECHNW-3CWT180042022-05-03
06973305010286Calming Heat Sauna WrapCHSW-3CWT42001/317832022-05-03
06973305010071SHARPER IMAGE315802020-11-03
06973305010088SHARPER IMAGE315792020-11-03
06973305010095SHARPER IMAGE315812020-11-03
06973305010194All star7716442021-09-30
06973305010170All starCWT170032021-04-30
06973305010101SHARPER IMAGECWT120062020-12-22
06973305010125SHARPER IMAGE315842020-12-22
06973305010132SHARPER IMAGECWT110062020-12-22
06973305010002SHARPER IMAGECWT031062020-05-20
06973305010019SHARPER IMAGE314562020-05-20
06973305010026SHARPER IMAGECWT051122020-05-21
06973305010033SHARPER IMAGE 723070-5072020-06-23
06973305010040SHARPER IMAGE723070-4742020-06-23

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