FDA.reportPublic FDA data

HEALAX i Shoulder

Primary DI
08800132500025
Brand
HEALAX i Shoulder
Company
HANILMEDICAL CO.,LTD.
Model
CGM ESA-SD1501
Published
2021-06-22
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
08800132500025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800132500025088001325000258800132500025

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
687625082
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800132500001Ceramix mat M1CGM EMT-MS16012021-06-22
08800132500018Ceramix mat S1CGM EMT-SS16072021-06-22

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