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)

DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

K-Number: K864956 · 1987-03-09

ApplicantLa Jolla Technology, Inc.
Decision Date1987-03-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. is the device name listed in this FDA 510(k) record. The listed applicant is La Jolla Technology, Inc.. It received FDA 510(k) clearance on 1987-03-09 under 510(k) number K864956. 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 DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.?

DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. is a medical device that received FDA 510(k) clearance on 1987-03-09. The listed applicant is La Jolla Technology, Inc.. The 510(k) number is K864956.

When did DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. receive FDA 510(k) clearance?

DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. received FDA 510(k) clearance on 1987-03-09, under 510(k) number K864956.

Who is the listed applicant for DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.?

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

What is the FDA product code for DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.?

The FDA product code for DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. 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 La Jolla 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.

K870160DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENSK854204DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENSK832888ECG INTERFERENCE FILTER TF-03K830932NYNEX II

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.

↑