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FDA 510(k)

GYMFORM ABS-A-ROUND

K-Number: K130074 · 2013-08-15

ApplicantWell Brain International , Ltd.
Decision Date2013-08-15
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GYMFORM ABS-A-ROUND is the device name listed in this FDA 510(k) record. The listed applicant is Well Brain International , Ltd.. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K130074. 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 GYMFORM ABS-A-ROUND?

GYMFORM ABS-A-ROUND is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Well Brain International , Ltd.. The 510(k) number is K130074.

When did GYMFORM ABS-A-ROUND receive FDA 510(k) clearance?

GYMFORM ABS-A-ROUND received FDA 510(k) clearance on 2013-08-15, under 510(k) number K130074.

Who is the listed applicant for GYMFORM ABS-A-ROUND?

The FDA 510(k) record lists Well Brain International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYMFORM ABS-A-ROUND?

The FDA product code for GYMFORM ABS-A-ROUND 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 Well Brain International , 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.

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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

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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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