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FDA 510(k)

SLENDERTONE® Connect Abs, Type 570

K-Number: K161974 · 2016-11-01

ApplicantBio-Medical Research, Ltd.
Decision Date2016-11-01
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE® Connect Abs, Type 570 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 2016-11-01 under 510(k) 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. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K161974.

When did SLENDERTONE® Connect Abs, Type 570 receive FDA 510(k) clearance?

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

Who is the listed applicant for SLENDERTONE® Connect Abs, Type 570?

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® Connect Abs, Type 570?

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