FDA 510(k)

SLENDERTONE Evolve Abs, Type 735

K-Number: K203513 · 2021-02-10

Decision Date2021-02-10

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

SLENDERTONE Evolve Abs, Type 735 is a medical device manufactured by Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2021-02-10 under approval number K203513. 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 Evolve Abs, Type 735?

SLENDERTONE Evolve Abs, Type 735 is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Bio-Medical Research, Ltd.. The 510(k) number is K203513.

When was SLENDERTONE Evolve Abs, Type 735 approved by the FDA?

SLENDERTONE Evolve Abs, Type 735 received FDA 510(k) clearance on 2021-02-10, under approval number K203513.

What company makes SLENDERTONE Evolve Abs, Type 735?

SLENDERTONE Evolve Abs, Type 735 is manufactured by Bio-Medical Research, Ltd..

What is the FDA product code for SLENDERTONE Evolve Abs, Type 735?

The FDA product code for SLENDERTONE Evolve Abs, Type 735 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.