FDA.reportPublic FDA data

TB12 VIBRATING PLIABILITY SPHERE

Primary DI
04580657301010
Brand
TB12 VIBRATING PLIABILITY SPHERE
Company
DREAM FACTORY INC.
Model
VBALL-BLK-02A
Device description
Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being.
Published
2021-01-12
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
04580657301010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580657301010045806573010104580657301010

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
698505802
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580657301027TB12 VIBRATING PLIABILITY MINI SPHEREVMINI-BLK-01A2021-04-14
04580657301003TB12 VIBRATING PLIABILITY ROLLERVPLI-RED-02A2021-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
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