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WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N

K100969 Class II Traditional
Decision Date
2010-09-20
Sponsor / Applicant
Wmi Enterprises, LLC

Technical Specification

510(k) Submission ID K100969
Product Code JOW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5800
Decision Date 2010-09-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N received FDA 510(k) clearance under submission number K100969, sponsored by Wmi Enterprises, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-09-20.

Classification & Regulation

This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.