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FDA 510(k)

SLENDERTONE FLEX MAX, MODEL 517 US

K-Number: K100556 · 2010-08-02

ApplicantBio-Medical Research, Ltd.
Decision Date2010-08-02
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE FLEX MAX, MODEL 517 US 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 2010-08-02 under 510(k) number K100556. 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 FLEX MAX, MODEL 517 US?

SLENDERTONE FLEX MAX, MODEL 517 US is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K100556.

When did SLENDERTONE FLEX MAX, MODEL 517 US receive FDA 510(k) clearance?

SLENDERTONE FLEX MAX, MODEL 517 US received FDA 510(k) clearance on 2010-08-02, under 510(k) number K100556.

Who is the listed applicant for SLENDERTONE FLEX MAX, MODEL 517 US?

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 FLEX MAX, MODEL 517 US?

The FDA product code for SLENDERTONE FLEX MAX, MODEL 517 US is NGX.

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Official Source

View on FDA Database →

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

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