FDA.reportPublic FDA data

silverfox

Primary DI
06973134771358
Brand
silverfox
Company
Silverfox Corporation Limited
Model
1005
Published
2025-07-09
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
06973134771358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973134771358069731347713586973134771358

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy system, professional-useAn assembly of electrically-powered devices designed for professional use to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529252597
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973134773017sliverfox9000N2026-05-27
06973134771549silverfoxF-815A2026-02-05
06973134771228silverfoxF-8032025-07-09
06973134771426silverfox10032025-07-09
06973134771433silverfoxF-826A2025-07-09
06973134771402silverfoxF-367A2025-02-19
06973134771419silverfoxF-9052025-02-19
06973134771365silverfoxF-311A2025-01-06
06973134771372silverfoxF-3812025-01-06
06973134771389silverfoxF-3622025-01-06
06973134771396silverfoxF-3652025-01-06
06973134771013silverfoxF-311A2023-12-13
06973134771020silverfoxF-312A2023-12-13
06973134771037silverfoxF-311B2023-12-13
06973134771044silverfoxF-312B2023-12-13
06973134771051silverfoxF-313A2023-12-13
06973134771068silverfoxF-313B2023-12-13
06973134771075silverfoxF-314A2023-12-13
06973134771082silverfoxF-314B2023-12-13
06973134771099silverfoxF-315A2023-12-13

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