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FDA 510(k)

SONIC-STIM

K-Number: K063135 · 2007-02-05

ApplicantNaimco, Inc.
Decision Date2007-02-05
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONIC-STIM is the device name listed in this FDA 510(k) record. The listed applicant is Naimco, Inc.. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K063135. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIC-STIM?

SONIC-STIM is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Naimco, Inc.. The 510(k) number is K063135.

When did SONIC-STIM receive FDA 510(k) clearance?

SONIC-STIM received FDA 510(k) clearance on 2007-02-05, under 510(k) number K063135.

Who is the listed applicant for SONIC-STIM?

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

What is the FDA product code for SONIC-STIM?

The FDA product code for SONIC-STIM is IMG.

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 Naimco, 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.

K050469EZ-STIK ELECTRODESK040495NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405

Related Devices (Code: IMG)

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.

K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd.K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)K120217SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbHK102524FUTURADr. Oliver Wenker, M.D., M.B.A.K111482SONICATOR PLUS 920Mettler Electronics Corp.

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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