FDA.reportPublic FDA data

n/a

Primary DI
06978863480045
Brand
n/a
Company
Fuan Aosika Electrical technology Co.,Ltd
Model
ASK-312
Device description
relax and relieve fatigue your body
Published
2025-07-31
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
06978863480045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978863480045069788634800456978863480045

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
15059383929379303650@qq.com

Regulatory Flags#

DUNS number
707773039
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978863480014n/aASK-1352025-07-31
06978863480021n/aASK-J1682025-07-31
06978863480038n/aASK-3102025-07-31
06978863480052n/a ASK-3132025-07-31
06978863480069n/a ASK-3162025-07-31
06978863480076n/a ASK-3182025-07-31

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Primary DI, Brand, Company table
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