TrueRelief P12T10

TrueRelief P12T10 is a Class II device made by Truerelief, cleared under FDA 510(k) K202186 on 23 Mar 2021 and listed in FDA GUDID since 8 Jan 2024 (UDI-DI B731P12T109), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB731P12T109 UDI-DI	Date8 Jan 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK202186	Date23 Mar 2021Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K202186

Across registries

2 registries list this device

FDA 510(k) K202186 decided 23 Mar 2021 Active
FDA GUDID UDI-DI B731P12T109 listed 8 Jan 2024 Listed

Timeline

2 dated events

23 Mar 2021 Cleared FDA 510(k) K202186
8 Jan 2024 Listed FDA GUDID B731P12T109

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: TrueRelief
Generic name: Transcutaneous electrical stimulation probe
Model / reference: P12T10

Primary DI / UDI-DI: B731P12T109
510(k) Number: K202186
FDA product code: GZJ
GMDN term: Transcutaneous electrical stimulation probe

Device class: Class II
Regulation number: 882.5890
GUDID distribution status: In Commercial Distribution

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Properties

Lot / batch number
Serial number
Manufacturing date

Other properties (12, all answered No)