FDA 510(k)

SLENDERTONE® Connect Abs, Type 570

K-Number: K161974 · 2016-11-01

Decision Date2016-11-01

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

SLENDERTONE® Connect Abs, Type 570 is a medical device manufactured by Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2016-11-01 under approval number K161974. 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® Connect Abs, Type 570?

SLENDERTONE® Connect Abs, Type 570 is a medical device that received FDA 510(k) clearance on 2016-11-01. It is manufactured by Bio-Medical Research, Ltd.. The 510(k) number is K161974.

When was SLENDERTONE® Connect Abs, Type 570 approved by the FDA?

SLENDERTONE® Connect Abs, Type 570 received FDA 510(k) clearance on 2016-11-01, under approval number K161974.

What company makes SLENDERTONE® Connect Abs, Type 570?

SLENDERTONE® Connect Abs, Type 570 is manufactured by Bio-Medical Research, Ltd..

What is the FDA product code for SLENDERTONE® Connect Abs, Type 570?

The FDA product code for SLENDERTONE® Connect Abs, Type 570 is NGX.

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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.