FDA.reportPublic FDA data

SOQI

Primary DI
06931294730059
Brand
SOQI
Company
HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd.
Model
HBM-618
Published
2023-11-01
Public version status
Update
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
06931294730059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931294730059069312947300596931294730059

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530364892
Device count
1
Premarket exempt
true
Serial number
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931294730066SOQIHH-1D2023-11-01
06931294730073SOQIYS-702023-11-01
06931294730011SOQIHM-5182023-11-01
06931294730028SOQIHM-518D2023-11-01
06931294730035SOQISW-2000N2023-11-01
06931294730042SOQISDM-8882023-11-01

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