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FDA 510(k)

GLOBUS PREMIUM MUSCLE STIMULATOR

K-Number: K061632 · 2007-04-30

ApplicantDomino S.R.L.
Decision Date2007-04-30
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GLOBUS PREMIUM MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Domino S.R.L.. It received FDA 510(k) clearance on 2007-04-30 under 510(k) number K061632. 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 GLOBUS PREMIUM MUSCLE STIMULATOR?

GLOBUS PREMIUM MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 2007-04-30. The listed applicant is Domino S.R.L.. The 510(k) number is K061632.

When did GLOBUS PREMIUM MUSCLE STIMULATOR receive FDA 510(k) clearance?

GLOBUS PREMIUM MUSCLE STIMULATOR received FDA 510(k) clearance on 2007-04-30, under 510(k) number K061632.

Who is the listed applicant for GLOBUS PREMIUM MUSCLE STIMULATOR?

The FDA 510(k) record lists Domino S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBUS PREMIUM MUSCLE STIMULATOR?

The FDA product code for GLOBUS PREMIUM MUSCLE STIMULATOR 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 Domino S.R.L. 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.

K071431GLOBUS GENESY 1100 STIMULATOR

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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