FDA.reportPublic FDA data

WELLBOX

Primary DI
B534WELLBOXDM1
Brand
WELLBOX
Company
L P G SYSTEMS
Model
WELLBOX
Published
2023-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
B534WELLBOXDM1PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
394430433
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
B534CELLUM6ALLIANCEMED1Cellu M6 AllianceCellu M6 Alliance Medical2023-05-02
B534CELLUM6LABMED1Cellu M6 Alliance LabCellu M6 Alliance Lab Medical2023-05-02
B534HUBER360MDEVO1HUBER360HUBER 360 EVOLUTION2023-05-02
B534HUBER360MDUS1HUBERHUBER2017-05-05

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