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FDA 510(k)

GEMORE MUSCLE CONDITIONER;

K-Number: K102926 · 2011-08-25

ApplicantGemore Technology Co, Ltd.
Decision Date2011-08-25
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEMORE MUSCLE CONDITIONER; 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 2011-08-25 under 510(k) number K102926. 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 GEMORE MUSCLE CONDITIONER;?

GEMORE MUSCLE CONDITIONER; is a medical device that received FDA 510(k) clearance on 2011-08-25. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K102926.

When did GEMORE MUSCLE CONDITIONER; receive FDA 510(k) clearance?

GEMORE MUSCLE CONDITIONER; received FDA 510(k) clearance on 2011-08-25, under 510(k) number K102926.

Who is the listed applicant for GEMORE MUSCLE CONDITIONER;?

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 GEMORE MUSCLE CONDITIONER;?

The FDA product code for GEMORE MUSCLE CONDITIONER; is NGX.

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Other records listing Gemore Technology Co, Ltd. 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.

K190988GIM-STIM OTC TENS/EMS SystemK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORK122948GEM-STIM COMBO STIMULATORK120569GEMORE TENS SYSTEMK102933GEM-TONE BODY TRAINING SYSTEMK091833GEM-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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