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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K143202
Device Name ANGIO-PRESS DVT Compression Device Model Name: IPCS
Applicant
Pegasus Medical Supply, Inc.
# 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City
Taoyuan County,  TW 32060
Applicant Contact PAO-MING SHIH
Correspondent
Acmebiotechs Co., Ltd.
# 45, Minsheng Rd. Danshui Town
New Taipei City,  TW 251
Correspondent Contact Michael Lee
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/07/2014
Decision Date 07/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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