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FDA 510(k)

SPORT-ELEC BODY CONTROL SYSTEM

K-Number: K091865 · 2009-11-13

ApplicantSport-Elec
Decision Date2009-11-13
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPORT-ELEC BODY CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sport-Elec. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K091865. 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 SPORT-ELEC BODY CONTROL SYSTEM?

SPORT-ELEC BODY CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Sport-Elec. The 510(k) number is K091865.

When did SPORT-ELEC BODY CONTROL SYSTEM receive FDA 510(k) clearance?

SPORT-ELEC BODY CONTROL SYSTEM received FDA 510(k) clearance on 2009-11-13, under 510(k) number K091865.

Who is the listed applicant for SPORT-ELEC BODY CONTROL SYSTEM?

The FDA 510(k) record lists Sport-Elec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPORT-ELEC BODY CONTROL SYSTEM?

The FDA product code for SPORT-ELEC BODY CONTROL SYSTEM is NGX.

Related Clinical Trials

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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Other records listing Sport-Elec 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.

K092476SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4MK092142SPORT-ELEC BODY CONTROL SYSTEM BS

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

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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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