FDA.reportPublic FDA data

BlackOnyx

Primary DI
00860001881561
Brand
BlackOnyx
Company
Tama Research Corp.
Model
TA1021
Catalog number
TA1021
Device description
Medical device for aesthetic use and pain management.
Published
2023-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173093000TAMA BEMS deviceTama Research Corporation2018-06-05NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001881561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001881561008600018815618600018815610860001881561

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy systemAn assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent 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, plantar fasciitis); 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
968419551
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001881509BlueOnyx QuadTA1014TA10142023-11-29
00860001881516MiTAMA DeluxeTA1017TA10172023-11-29
00860001881523BlueOnyx ProTA1012TA10122023-11-29
00860001881547MiTAMA Renew PlusTA1015+TA1015+2023-11-29
00860001881554MiTAMA ClearTA1018TA10182023-11-29

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