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)

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS

K-Number: K062873 · 2007-03-20

ApplicantE.C.I. USA Corporation
Decision Date2007-03-20
Product CodeDWL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS is the device name listed in this FDA 510(k) record. The listed applicant is E.C.I. USA Corporation. It received FDA 510(k) clearance on 2007-03-20 under 510(k) number K062873. The device is classified under product code DWL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS?

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS is a medical device that received FDA 510(k) clearance on 2007-03-20. The listed applicant is E.C.I. USA Corporation. The 510(k) number is K062873.

When did SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS receive FDA 510(k) clearance?

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS received FDA 510(k) clearance on 2007-03-20, under 510(k) number K062873.

Who is the listed applicant for SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS?

The FDA 510(k) record lists E.C.I. USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS?

The FDA product code for SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS is DWL.

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

Related Devices (Code: DWL)

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.

K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.K122485ENCIRCLE COMPRESSION THERAPY STOCKINGEncircle Medical Devices , Ltd.K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOSBossong Hosiery Mills, Inc.K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE3M CompanyK123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, Inc.K123398DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation

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.

↑