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)

COMFY SERIES: EV-804, EV-805 & EV-806

K-Number: K071951 · 2007-09-05

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2007-09-05
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMFY SERIES: EV-804, EV-805 & EV-806 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2007-09-05 under 510(k) number K071951. 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 COMFY SERIES: EV-804, EV-805 & EV-806?

COMFY SERIES: EV-804, EV-805 & EV-806 is a medical device that received FDA 510(k) clearance on 2007-09-05. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K071951.

When did COMFY SERIES: EV-804, EV-805 & EV-806 receive FDA 510(k) clearance?

COMFY SERIES: EV-804, EV-805 & EV-806 received FDA 510(k) clearance on 2007-09-05, under 510(k) number K071951.

Who is the listed applicant for COMFY SERIES: EV-804, EV-805 & EV-806?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFY SERIES: EV-804, EV-805 & EV-806?

The FDA product code for COMFY SERIES: EV-804, EV-805 & EV-806 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 Everyway Medical Instruments Co.,Ltd 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.

K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4K222488Everyway Analog OTC TENSK213116Everyway Incontinence Stimulation SystemK202849Everyway Analog OTC TENS, model N103A/N302K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806

View all 27 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.

↑