Gemore

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Device Name

Electrodes

Model / Reference

FA5050, FA4080

Primary DI / UDI-DI

04712832960099

Basic UDI-DI

471283296electrode6N

EMDN Code

N010201 Tens system electrodes

Device Class

Class I

EU market of registration

Spain

EUDAMED SRN

TW-MF-000019446

Authorised representative

Luana Med. B.V. NL-AR-000002750

• Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series

  Class II

  FDA 510(k) K062675 Active Cleared 4 Jan 2007

• Gem-Tone Body Training System

  Class II

  FDA 510(k) K102933 Active Cleared 2 Sep 2011

• Gem-Twin Tens/ Models GM3XY/Z

  Class II

  FDA 510(k) K042559 Active Cleared 17 Nov 2004

• Low Back Pain Relief System /Models GM310PP, GM320PP, GM321PP, and GM330PP

  Class II

  FDA 510(k) K060222 Active Cleared 28 Apr 2006

• Gemore Muscle Conditioner;

  Class II

  FDA 510(k) K102926 Active Cleared 25 Aug 2011

• Gemore OTC TENS

  Class II

  CE/MDR FDA 510(k) K150681 Active Cleared 12 May 2015

See all devices from Gemore Technology Co., Ltd. →