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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K260426
Device Name MeCare Alpha (MCA2019)
Applicant
IVT Medical, Ltd.
Hatidhar St. 16
Ra'Anana,  IL 4366518
Applicant Contact Moris Topaz
Correspondent
IVT Medical, Ltd.
Hatidhar St. 16
Ra'Anana,  IL 4366518
Correspondent Contact Moris Topaz
Regulation Number878.4780
Classification Product Code
OMP  
Date Received02/10/2026
Decision Date 10/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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