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FDA 510(k)

SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20

K-Number: K070142 · 2007-03-23

ApplicantBio-Medical Research Corp.
Decision Date2007-03-23
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research Corp.. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K070142. 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 SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20?

SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Bio-Medical Research Corp.. The 510(k) number is K070142.

When did SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 receive FDA 510(k) clearance?

SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 received FDA 510(k) clearance on 2007-03-23, under 510(k) number K070142.

Who is the listed applicant for SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20?

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

What is the FDA product code for SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20?

The FDA product code for SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 is NGX.

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Other records listing Bio-Medical Research Corp. 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.

K071666SLENDERTONE ENERVIVE, MODEL 561K840149BMR POWERSTIMK840148BMR-16 CLINIC MUSCLE STIMULATORK840147BMR-2 MUSCLE STIMULATOR

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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