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)

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800

K-Number: K112074 · 2012-02-01

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2012-02-01
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 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 2012-02-01 under 510(k) number K112074. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800?

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 is a medical device that received FDA 510(k) clearance on 2012-02-01. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K112074.

When did EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 receive FDA 510(k) clearance?

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 received FDA 510(k) clearance on 2012-02-01, under 510(k) number K112074.

Who is the listed applicant for EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800?

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 EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800?

The FDA product code for EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 is ITH.

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: ITH)

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.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbHK103248INTEGRITY SPINAL CARE SYSTEMIntegra Life SciencesK101889DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEPivotal Health Solutions

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.

↑