FDA 510(k)

SLENDERTONE CoreFit Abs 8, Type 734

K-Number: K180688 · 2018-10-25

Decision Date2018-10-25

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

SLENDERTONE CoreFit Abs 8, Type 734 is a medical device manufactured by Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2018-10-25 under approval number K180688. 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 SLENDERTONE CoreFit Abs 8, Type 734?

SLENDERTONE CoreFit Abs 8, Type 734 is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Bio-Medical Research, Ltd.. The 510(k) number is K180688.

When was SLENDERTONE CoreFit Abs 8, Type 734 approved by the FDA?

SLENDERTONE CoreFit Abs 8, Type 734 received FDA 510(k) clearance on 2018-10-25, under approval number K180688.

What company makes SLENDERTONE CoreFit Abs 8, Type 734?

SLENDERTONE CoreFit Abs 8, Type 734 is manufactured by Bio-Medical Research, Ltd..

What is the FDA product code for SLENDERTONE CoreFit Abs 8, Type 734?

The FDA product code for SLENDERTONE CoreFit Abs 8, Type 734 is NGX.

Other Devices by Bio-Medical Research, Ltd.

K161974SLENDERTONE® Connect Abs, Type 570 DEN170049Innovo K203513SLENDERTONE Evolve Abs, Type 735

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

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