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MyOnyx

FDA UDI

Class II (US FDA UDI)

by Thought Technology Ltd.

Identity

Trade Name
MyOnyx FDA UDI
Generic Name
Psychophysiological biofeedback system FDA UDI
Model / Reference
SA9000 FDA UDI

Identifiers

Primary DI / UDI-DI
07540191000555 FDA UDI
510(k) Number
K053434 FDA UDI
FDA Product Code
HCC FDA UDI
KPI FDA UDI
IPF FDA UDI
GMDN Term
Psychophysiological biofeedback system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
876.5320 FDA UDI
890.5850 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: Physical therapy transcutaneous neuromuscular electrical stimulation systemPsychophysiological biofeedback systemPerineal orifice incontinence-control electrical stimulation system, professional

MyOnyx by Thought Technology Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perineal orifice incontinence-control electrical stimulation system, professional.

Cleared under the same submission

K053434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thought Technology Ltd.

Sources (1)

  • FDA UDI c5d11850-9499-4f01-8562-3dcf102e078b 33 fields · synced May 30, 2026