FDA.reportPublic FDA data

SHARPER IMAGE

Primary DI
06936189900685
Brand
SHARPER IMAGE
Company
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
Model
25in CHFWU-9
Catalog number
CWT24003
Device description
Calming heat Deluxe massaging Flexi Wrap. Input DC 5V, 1A, Power 5W. Heat 3 gears ,Shake 9 gears . This device complies with part 15 of FCC rules.
Published
2021-10-20
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
06936189900685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936189900685069361899006856936189900685

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

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
Serial number
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
06936189900708SHARPER IMAGECHBWO-3CWT410032022-04-10
06936189900678SHARPER IMAGE25in CHFWU-3CWT310032021-10-20
06936189900067SHARPER IMAGE25 in2021-09-27

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