FDA.reportPublic FDA data

SHARPER IMAGE

Primary DI
06936189900715
Brand
SHARPER IMAGE
Company
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
Model
CHBWON-3
Catalog number
CWT41003-31800-31781
Device description
Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings). 3 Heat,3 Vibration,3 Lumbar. Thisdevice complies with part 15 of FCC rules
Published
2022-06-10
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
06936189900715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936189900715069361899007156936189900715

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
06936189900722SHARPER IMAGECHBWON-931801-317822022-06-10
06936189900708SHARPER IMAGECHBWO-3CWT410032022-04-10
06936189900678SHARPER IMAGE25in CHFWU-3CWT310032021-10-20
06936189900685SHARPER IMAGE25in CHFWU-9CWT240032021-10-20
06936189900067SHARPER IMAGE25 in2021-09-27

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