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BlackOnyx

FDA UDI

Class II (US FDA UDI)

by Tama Research Corporation

Identity

Trade Name
BlackOnyx FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Device Name
Medical device for aesthetic use and pain management. FDA UDI
Model / Reference
TA1021 FDA UDI
Description
Medical device for aesthetic use and pain management. FDA UDI

Identifiers

Catalog Number
TA1021 FDA UDI
Primary DI / UDI-DI
00860001881561 FDA UDI
510(k) Number
K173093 FDA UDI
FDA Product Code
NFO FDA UDI
GMDN Term
Multi-modality physical therapy system, professional-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality physical therapy system, professional-use

BlackOnyx by Tama Research Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality physical therapy system, professional-use.

Cleared under the same submission

K173093 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tama Research Corporation

Sources (1)

  • FDA UDI 2030d525-643c-4916-972d-19bd03f4cb72 35 fields · synced May 30, 2026