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FDA 510(k)

VITALITY SYSTEM

K-Number: K993143 · 1999-12-27

ApplicantSoma Blue, Inc.
Decision Date1999-12-27
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Soma Blue, Inc.. It received FDA 510(k) clearance on 1999-12-27 under 510(k) number K993143. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALITY SYSTEM?

VITALITY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-27. The listed applicant is Soma Blue, Inc.. The 510(k) number is K993143.

When did VITALITY SYSTEM receive FDA 510(k) clearance?

VITALITY SYSTEM received FDA 510(k) clearance on 1999-12-27, under 510(k) number K993143.

Who is the listed applicant for VITALITY SYSTEM?

The FDA 510(k) record lists Soma Blue, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALITY SYSTEM?

The FDA product code for VITALITY SYSTEM is LKY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Soma Blue, Inc. 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.

K993142ELITE CUSTOM

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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