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FDA 510(k)

GEM-TONE BODY TRAINING SYSTEM

K-Number: K102933 · 2011-09-02

ApplicantGemore Technology Co, Ltd.
Decision Date2011-09-02
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEM-TONE BODY TRAINING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2011-09-02 under 510(k) number K102933. 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 GEM-TONE BODY TRAINING SYSTEM?

GEM-TONE BODY TRAINING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-02. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K102933.

When did GEM-TONE BODY TRAINING SYSTEM receive FDA 510(k) clearance?

GEM-TONE BODY TRAINING SYSTEM received FDA 510(k) clearance on 2011-09-02, under 510(k) number K102933.

Who is the listed applicant for GEM-TONE BODY TRAINING SYSTEM?

The FDA 510(k) record lists Gemore Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM-TONE BODY TRAINING SYSTEM?

The FDA product code for GEM-TONE BODY TRAINING SYSTEM is NGX.

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Other records listing Gemore Technology Co, Ltd. as applicant

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K190988GIM-STIM OTC TENS/EMS SystemK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORK122948GEM-STIM COMBO STIMULATORK120569GEMORE TENS SYSTEMK102926GEMORE MUSCLE CONDITIONER;K091833GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

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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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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