Gemore Muscle Conditioner;

510(k) Number

K102926 ↗

FDA product code

NGX

FDA applicant

Gemore Technology Co, Ltd.

Device class

Class II

Regulation

21 CFR Part 890.5850

Advisory committee

Physical Medicine

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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.

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

• CoreLevee by Lutronic Corporation
• miha bodytec i-body connect wireless by Miha Bodytec GmbH
• Revitive Medic; Revitive MV; Revitive LV by Actegy, Ltd.
• Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) by Beijing ADSS Development Co., Ltd.
• miha bodytec m.ove by Miha Bodytec GmbH
• truFlex by SYRMA JOHARI MEDTECH LIMITED
• Revitive Medic Plus, Revitive Advanced 2 by Actegy, Ltd.
• Compex Wireless USA by DJO, LLC
• CoolTone by Zimmer Medizinsystems GmbH
• ION Magnum Genius by Ion Genius, Inc.

• 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

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