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TrueRelief

FDA UDI

Class II (US FDA UDI)

by Truerelief

Identity

Trade Name
TrueRelief FDA UDI
Generic Name
Transcutaneous electrical stimulation probe FDA UDI
Model / Reference
P12S FDA UDI

Identifiers

Primary DI / UDI-DI
B731P12S0 FDA UDI
510(k) Number
K202186 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Transcutaneous electrical stimulation probe 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

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous electrical stimulation probe

TrueRelief by Truerelief — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation probe.

Cleared under the same submission

K202186 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Truerelief

Sources (1)

  • FDA UDI c11ba55c-dd89-4e08-9da3-33405d3376ac 33 fields · synced May 29, 2026