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FDA 510(k)

GLOBUS GENESY 1100 STIMULATOR

K-Number: K071431 · 2007-09-21

ApplicantDomino S.R.L.
Decision Date2007-09-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GLOBUS GENESY 1100 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 2007-09-21 under 510(k) number K071431. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBUS GENESY 1100 STIMULATOR?

GLOBUS GENESY 1100 STIMULATOR is a medical device that received FDA 510(k) clearance on 2007-09-21. The listed applicant is Domino S.R.L.. The 510(k) number is K071431.

When did GLOBUS GENESY 1100 STIMULATOR receive FDA 510(k) clearance?

GLOBUS GENESY 1100 STIMULATOR received FDA 510(k) clearance on 2007-09-21, under 510(k) number K071431.

Who is the listed applicant for GLOBUS GENESY 1100 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 GENESY 1100 STIMULATOR?

The FDA product code for GLOBUS GENESY 1100 STIMULATOR is IPF.

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.

K061632GLOBUS PREMIUM MUSCLE STIMULATOR

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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