FDA.reportPublic FDA data

OSUN MEDICAL., INC.

Primary DI
08800123100029
Brand
OSUN MEDICAL., INC.
Company
Osun Medical Co., Ltd.
Model
ELECTRIC CUPPING MACHINE, MAGICAL 7
Published
2021-09-01
Public version status
New
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
08800123100029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800123100029088001231000298800123100029

GMDN Terms#

Term, Definition table
TermDefinition
Cupping therapy deviceA dome typically made of glass or hard plastic intended to be used to manually produce sites of suction on the surface of the skin, or other soft tissues, in the practice of cupping therapy used by acupuncture and traditional Chinese medicine practitioners for localized healing or energy flow. The device is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690236109
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800123100036OSUN MEDICAL., INC.ELECTRIC CUPPING MACHINE, MAGICAL 92021-09-01

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Primary DI, Brand, Company table
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