Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AUTO-TENS MODEL II SINGLE CHANNEL

K-Number: K823465 · 1983-02-02

ApplicantCbc Corp.
Decision Date1983-02-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUTO-TENS MODEL II SINGLE CHANNEL is the device name listed in this FDA 510(k) record. The listed applicant is Cbc Corp.. It received FDA 510(k) clearance on 1983-02-02 under 510(k) number K823465. 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 AUTO-TENS MODEL II SINGLE CHANNEL?

AUTO-TENS MODEL II SINGLE CHANNEL is a medical device that received FDA 510(k) clearance on 1983-02-02. The listed applicant is Cbc Corp.. The 510(k) number is K823465.

When did AUTO-TENS MODEL II SINGLE CHANNEL receive FDA 510(k) clearance?

AUTO-TENS MODEL II SINGLE CHANNEL received FDA 510(k) clearance on 1983-02-02, under 510(k) number K823465.

Who is the listed applicant for AUTO-TENS MODEL II SINGLE CHANNEL?

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

What is the FDA product code for AUTO-TENS MODEL II SINGLE CHANNEL?

The FDA product code for AUTO-TENS MODEL II SINGLE CHANNEL 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 Cbc Corp. 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.

K832337AUTO-TENS MODEL VK823466AUTO-TENS MODEL III DUAL CHANNEL REPLACEK823467AUTO-TENS MODEL I DISPOS. SINGLE CHANK823464AUTO-TENS MODEL IV -DUAL CHANNEL FULL

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑