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)

XCEL MODEL XE-1

K-Number: K830992 · 1983-08-12

ApplicantElectrocaine Medical System
Decision Date1983-08-12
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XCEL MODEL XE-1 is the device name listed in this FDA 510(k) record. The listed applicant is Electrocaine Medical System. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K830992. 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 XCEL MODEL XE-1?

XCEL MODEL XE-1 is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Electrocaine Medical System. The 510(k) number is K830992.

When did XCEL MODEL XE-1 receive FDA 510(k) clearance?

XCEL MODEL XE-1 received FDA 510(k) clearance on 1983-08-12, under 510(k) number K830992.

Who is the listed applicant for XCEL MODEL XE-1?

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

What is the FDA product code for XCEL MODEL XE-1?

The FDA product code for XCEL MODEL XE-1 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 Electrocaine Medical System 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.

K924413FLOWSCANK926336AUDIOSCANK844638ELECTROCAINE MODEL SR-IVK800317DAVOL EMS ADAPTER, CAT. NO. 13-7664

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.

↑