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)

TRANSCUTANEOUS ELEC. NERVE STIMULATOR

K-Number: K813501 · 1981-12-29

ApplicantEmpi
Decision Date1981-12-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELEC. NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813501. 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 TRANSCUTANEOUS ELEC. NERVE STIMULATOR?

TRANSCUTANEOUS ELEC. NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Empi. The 510(k) number is K813501.

When did TRANSCUTANEOUS ELEC. NERVE STIMULATOR receive FDA 510(k) clearance?

TRANSCUTANEOUS ELEC. NERVE STIMULATOR received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813501.

Who is the listed applicant for TRANSCUTANEOUS ELEC. NERVE STIMULATOR?

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

What is the FDA product code for TRANSCUTANEOUS ELEC. NERVE STIMULATOR?

The FDA product code for TRANSCUTANEOUS ELEC. NERVE STIMULATOR 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 Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

View all 60 devices →

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.

↑