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FDA 510(k)

SLENDERTONE GYMBODY, MODEL 512-01

K-Number: K052969 · 2005-11-16

ApplicantBio-Medical Research, Ltd.
Decision Date2005-11-16
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE GYMBODY, MODEL 512-01 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 2005-11-16 under 510(k) number K052969. 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 GYMBODY, MODEL 512-01?

SLENDERTONE GYMBODY, MODEL 512-01 is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K052969.

When did SLENDERTONE GYMBODY, MODEL 512-01 receive FDA 510(k) clearance?

SLENDERTONE GYMBODY, MODEL 512-01 received FDA 510(k) clearance on 2005-11-16, under 510(k) number K052969.

Who is the listed applicant for SLENDERTONE GYMBODY, MODEL 512-01?

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 GYMBODY, MODEL 512-01?

The FDA product code for SLENDERTONE GYMBODY, MODEL 512-01 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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