FDA 510(k)

Fitness Belt (Model: KLT-07)

K-Number: K231136 · 2023-06-16

ApplicantShenzhen Kelutongda Industrial Co., Ltd.

Decision Date2023-06-16

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Fitness Belt (Model: KLT-07) is a medical device manufactured by Shenzhen Kelutongda Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-06-16 under approval number K231136. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fitness Belt (Model: KLT-07)?

Fitness Belt (Model: KLT-07) is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Shenzhen Kelutongda Industrial Co., Ltd.. The 510(k) number is K231136.

When was Fitness Belt (Model: KLT-07) approved by the FDA?

Fitness Belt (Model: KLT-07) received FDA 510(k) clearance on 2023-06-16, under approval number K231136.

What company makes Fitness Belt (Model: KLT-07)?

Fitness Belt (Model: KLT-07) is manufactured by Shenzhen Kelutongda Industrial Co., Ltd..

What is the FDA product code for Fitness Belt (Model: KLT-07)?

The FDA product code for Fitness Belt (Model: KLT-07) is NGX.

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.