1byone PL-029K16B

by 1BYONEPRODUCTS Inc.

1byone PL-029K16B is a Class II device made by 1BYONEPRODUCTS Inc., listed in FDA GUDID since 12 Dec 2019 (UDI-DI 00858069007061), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00858069007061 UDI-DI	Date12 Dec 2019Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00858069007061

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: 1byone
Generic name: Analgesic transcutaneous electrical nerve stimulation system
Model / reference: PL-029K16B

Primary DI / UDI-DI: 00858069007061
FDA product code: NGX, IRT, NYN, NUH
GMDN term: Analgesic transcutaneous electrical nerve stimulation system

Device class: Class II
Regulation number: 890.5850, 890.5740, 882.5890
GUDID distribution status: In Commercial Distribution

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Properties

Convenience kit

Other properties (14, all answered No)