Myotrac 4000 60Hz Unit PP

FDA UDI

Class II (US FDA UDI)

by Thought Technology Ltd.

Identity

Trade Name: Myotrac 4000 60Hz Unit PP FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Model / Reference: SA4000P FDA UDI

Identifiers

Primary DI / UDI-DI: 07540191000012 FDA UDI
510(k) Number: K881416 FDA UDI
FDA Product Code: HCC FDA UDI
GMDN Term: Psychophysiological biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Psychophysiological biofeedback system

Myotrac 4000 60Hz Unit PP by Thought Technology Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Psychophysiological biofeedback system.

Axon — EXSURGO LIMITED · Class II
dorsaVi — DORSAVI LTD · Class II
Trigno Avanti Mini Sensor — DELSYS, INC. · Class II
Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
FlexiCAP — DEYMED Diagnostic s.r.o. · Class II
MyoPro — Myomo, Inc. · Class II
Axon 2 — EXSURGO LIMITED · Class II
Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II

Cleared under the same submission

K881416 also covers:

Sensor, Myoscan EMG — Thought Technology Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Thought Technology Ltd.

Sources (1)

FDA UDI f8030001-b8ae-4769-886e-d9a8163fad26 33 fields · synced Jun 7, 2026