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FDA 510(k)

SLENDERTONE Evolve Abs, Type 735

K-Number: K203513 · 2021-02-10

ApplicantBio-Medical Research, Ltd.
Decision Date2021-02-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE Evolve Abs, Type 735 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) 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. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K203513.

When did SLENDERTONE Evolve Abs, Type 735 receive FDA 510(k) clearance?

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

Who is the listed applicant for SLENDERTONE Evolve Abs, Type 735?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bio-Medical Research, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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