FDA.reportPublic FDA data

Shenzhen Wells Optoelectronics Co.,Ltd.

Primary DI
06977182819192
Brand
Shenzhen Wells Optoelectronics Co.,Ltd.
Company
Shenzhen Wells Optoelectronics Co.,Ltd.
Model
919AS
Device description
Multifunction Body Massager Machine/919AS
Published
2024-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977182819192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977182819192069771828191926977182819192

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

Regulatory Flags#

DUNS number
549645451
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
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.DZ012024-06-16
06977182812018Shenzhen Wells Optoelectronics Co.,Ltd.IR2012024-06-16
06977182819390Shenzhen Wells Optoelectronics Co.,Ltd.9392024-06-16
16977182810073Shenzhen Wells Optoelectronics Co.,Ltd.CD07S2024-06-16
06977182810014Shenzhen Wells Optoelectronics Co.,Ltd.DZ-012024-06-11

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Primary DI, Brand, Company table
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