1BYONE 725EU-0003

by 1BYONEPRODUCTS Inc.

1BYONE 725EU-0003 is a Class II device made by 1BYONEPRODUCTS Inc., cleared under FDA 510(k) K153520 on 5 May 2016 and listed in FDA GUDID since 24 May 2017 (UDI-DI 00858069007009), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

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	Number00858069007009 UDI-DI	Date24 May 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153520	Date5 May 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00858069007009
FDA 510(k) database 510(k) number K153520

Across registries

2 registries list this device

FDA 510(k) K153520 decided 5 May 2016 Active
FDA GUDID UDI-DI 00858069007009 listed 24 May 2017 Listed

Timeline

2 dated events

5 May 2016 Cleared FDA 510(k) K153520
24 May 2017 Listed FDA GUDID 00858069007009

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: 1BYONE
Generic name: Analgesic transcutaneous electrical nerve stimulation system
Model / reference: 725EU-0003

Primary DI / UDI-DI: 00858069007009
510(k) Number: K153520
FDA product code: NGX
GMDN term: Analgesic transcutaneous electrical nerve stimulation system

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

Similar devices in this category

Other devices filed under Analgesic transcutaneous electrical nerve stimulation system.

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Properties

Single use
Convenience kit

Other properties (13, all answered No)