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FDA 510(k)

ACTION POTENTIAL SIMULATION THERAPY DEVICE

K-Number: K955470 · 1996-10-22

ApplicantNeurotech, Inc.
Decision Date1996-10-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTION POTENTIAL SIMULATION THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Neurotech, Inc.. It received FDA 510(k) clearance on 1996-10-22 under 510(k) number K955470. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTION POTENTIAL SIMULATION THERAPY DEVICE?

ACTION POTENTIAL SIMULATION THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1996-10-22. The listed applicant is Neurotech, Inc.. The 510(k) number is K955470.

When did ACTION POTENTIAL SIMULATION THERAPY DEVICE receive FDA 510(k) clearance?

ACTION POTENTIAL SIMULATION THERAPY DEVICE received FDA 510(k) clearance on 1996-10-22, under 510(k) number K955470.

Who is the listed applicant for ACTION POTENTIAL SIMULATION THERAPY DEVICE?

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

What is the FDA product code for ACTION POTENTIAL SIMULATION THERAPY DEVICE?

The FDA product code for ACTION POTENTIAL SIMULATION THERAPY DEVICE is GZJ.

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 Neurotech, 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.

K860314NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281K860315NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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