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FDA 510(k)

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515

K-Number: K030708 · 2003-06-25

ApplicantBio-Medical Research, Ltd.
Decision Date2003-06-25
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 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 2003-06-25 under 510(k) number K030708. 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 ABDOMINAL TRAINING SYSTEM, TYPE 515?

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K030708.

When did SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 receive FDA 510(k) clearance?

SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 received FDA 510(k) clearance on 2003-06-25, under 510(k) number K030708.

Who is the listed applicant for SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515?

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 ABDOMINAL TRAINING SYSTEM, TYPE 515?

The FDA product code for SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 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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