PainKARE

510(k) K151034

PainKARE is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Triowave Technologies, cleared under FDA 510(k) K151034 on 21 Nov 2015, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K151034↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK151034	Date21 Nov 2015Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K151034

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K151034
FDA product code: NUH

Device class: Class II
Regulation: 21 CFR Part 882.5890
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

Devices cleared under K151034

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K151034
		UDI-DI	Size and differences
PainKARE PK001 Triowave Technologies	PK001	00866946000302	—	On the market

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Other devices from Triowave Technologies

PainKARE PK001

Class II