Skip to content

Ab Command Dual Channel Fitness Belt

by Leto Enterprises Incorporation

510(k) K122414

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK122414 Date21 Dec 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NGX
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ab Command Dual Channel Fitness Belt is a device intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation through skin contact electrodes. It functions as a dual channel fitness system designed for muscle stimulation.

This device has received FDA 510(k) clearance under K122414. It is manufactured by Leto Enterprises Incorporation and is categorized under product code NGX.

Other devices from Leto Enterprises Incorporation

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Ab Command Dual Channel Fitness Belt?

    This device is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation through skin contact electrodes. It functions as a dual channel fitness system designed specifically for muscle stimulation.

  • What is the regulatory status of this fitness belt?

    The Ab Command Dual Channel Fitness Belt has received FDA 510(k) clearance under K122414. It is categorized under product code NGX and was determined to be substantially equivalent to existing devices by the Physical Medicine advisory committee.

  • Who is the manufacturer of this device?

    The device is manufactured by Leto Enterprises Incorporation, located in the Futian District of Shenzhen, China.