Blue Hand 1.5RD Xtfa

by Bio Protech USA, Inc.

Blue Hand 1.5RD Xtfa is a Class II device made by Bio Protech USA, Inc., cleared under FDA 510(k) K042301 on 3 Sep 2004 and listed in FDA GUDID since 28 Jun 2016 (UDI-DI 00817120020289), 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	Number00817120020289 UDI-DI	Date28 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK042301	Date3 Sep 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817120020289
FDA 510(k) database 510(k) number K042301

Across registries

2 registries list this device

FDA 510(k) K042301 decided 3 Sep 2004 Active
FDA GUDID UDI-DI 00817120020289 listed 28 Jun 2016 Listed

Timeline

2 dated events

3 Sep 2004 Cleared FDA 510(k) K042301
28 Jun 2016 Listed FDA GUDID 00817120020289

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Blue Hand
Generic name: Transcutaneous electrical stimulation electrode, single-use
Model / reference: 1.5RD XTFA

Primary DI / UDI-DI: 00817120020289
510(k) Number: K042301
FDA product code: GXY
GMDN term: Transcutaneous electrical stimulation electrode, single-use

Device class: Class II
Regulation number: 882.1320
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)