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)

TENS DEVICE

K-Number: K812138 · 1981-08-20

ApplicantWestern Advanced Technology, Inc.
Decision Date1981-08-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Western Advanced Technology, Inc.. It received FDA 510(k) clearance on 1981-08-20 under 510(k) number K812138. 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 TENS DEVICE?

TENS DEVICE is a medical device that received FDA 510(k) clearance on 1981-08-20. The listed applicant is Western Advanced Technology, Inc.. The 510(k) number is K812138.

When did TENS DEVICE receive FDA 510(k) clearance?

TENS DEVICE received FDA 510(k) clearance on 1981-08-20, under 510(k) number K812138.

Who is the listed applicant for TENS DEVICE?

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

What is the FDA product code for TENS DEVICE?

The FDA product code for TENS 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 Western Advanced Technology, 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.

K822411SYSTEM 80 FACEPLATE-IN-THE-EAR #F1K813557AUDITORY STIMULATORK811790OCTOTOXIC SCREENERK811772AUDITORY LOCALIZERK802324E1 SERIES HEARING AID

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.

↑