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FDA 510(k)

X2ABS DUAL CHANNEL FITNESS BELT

K-Number: K102295 · 2011-02-18

ApplicantLeto Enterprises Incorporation
Decision Date2011-02-18
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

X2ABS DUAL CHANNEL FITNESS BELT is the device name listed in this FDA 510(k) record. The listed applicant is Leto Enterprises Incorporation. It received FDA 510(k) clearance on 2011-02-18 under 510(k) number K102295. 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 X2ABS DUAL CHANNEL FITNESS BELT?

X2ABS DUAL CHANNEL FITNESS BELT is a medical device that received FDA 510(k) clearance on 2011-02-18. The listed applicant is Leto Enterprises Incorporation. The 510(k) number is K102295.

When did X2ABS DUAL CHANNEL FITNESS BELT receive FDA 510(k) clearance?

X2ABS DUAL CHANNEL FITNESS BELT received FDA 510(k) clearance on 2011-02-18, under 510(k) number K102295.

Who is the listed applicant for X2ABS DUAL CHANNEL FITNESS BELT?

The FDA 510(k) record lists Leto Enterprises Incorporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X2ABS DUAL CHANNEL FITNESS BELT?

The FDA product code for X2ABS DUAL CHANNEL FITNESS BELT 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 Leto Enterprises Incorporation 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.

K122414AB COMMAND DUAL CHANNEL FITNESS BELT

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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