FDA.reportPublic FDA data

HuBDIC Leg Massager

Primary DI
16975977230020
Brand
HuBDIC Leg Massager
Company
Dongguan City Umed Technology Co., Ltd
Model
MD-100
Device description
The product is composed of built-in rechargeable lithium battery, air pump, control valve, massage air bag and hot compress. It is used to massage the human calf, which can relieve leg fatigue, improve leg blood circulation and prevent varicose veins.
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
16975977230020PackageGS120In Commercial Distribution
06975977230023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697597723002016975977230020
06975977230023069759772300236975977230023

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602090959
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975977230023HuBDIC Leg MassagerMD-1002023-08-10
06975977230016LAMEVEN Eye MassagerMD-2062022-12-20

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