FDA.reportPublic FDA data

SHARPER IMAGE

Primary DI
06936189900708
Brand
SHARPER IMAGE
Company
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
Model
CHBWO-3
Catalog number
CWT41003
Device description
Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings).3 Heat,3 Vibration,3 Lumbar. This device complies with part 15 of FCC rules.
Published
2022-04-10
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
06936189900708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936189900708069361899007086936189900708

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
548239775
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
06936189900869CALMING HEATCHNSCC3-3CWT820042024-06-16
06936189900760CALMING HEATCHS3-3CWT55003-318402024-02-19
06936189900777CALMING HEATCHS3-9318412024-02-19
06936189900784CALMING HEATCHNS3-3CWT68104-31908-319172024-02-19
06936189900791CALMING HEATCHNS3-931909-319182024-02-19
06936189900821WUSH31963,V56965,319622024-02-19
06936189900838WUSH319642024-02-19
06936189900852WUSHWUSH12022024-02-19
06936189900746WUSHWUSH0106,WUSH0706,WUSH0906,WUSH0103,WUSH10122023-03-06
06936189900753WUSH317692023-03-06
06936189900715SHARPER IMAGECHBWON-3CWT41003-31800-317812022-06-10
06936189900722SHARPER IMAGECHBWON-931801-317822022-06-10
06936189900678SHARPER IMAGE25in CHFWU-3CWT310032021-10-20
06936189900685SHARPER IMAGE25in CHFWU-9CWT240032021-10-20
06936189900067SHARPER IMAGE25 in2021-09-27

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