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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K251130
Device Name Portable Oxygen Concentrator (JM-P50A)
Applicant
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
#36 Danyan Rd.
Danyang,  CN 212300
Applicant Contact Yu Yao
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Todd Courtney
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/11/2025
Decision Date 08/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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