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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 K252616
Device Name Portable oxygen concentrator (JLO-190P)
Applicant
Shenzhen Homed Medical Device Co., Ltd.
Rm. 1601-1604, A Bldg., Jinxiu Iii, # 85 Hudi Pai
Songxuan Community, Guanhu St., Longhua District
Shenzhen,  CN 518000
Applicant Contact Shengming Shi
Correspondent
Shenzhen Homed Medical Device Co., Ltd.
Rm. 1601-1604, A Bldg., Jinxiu Iii, # 85 Hudi Pai
Songxuan Community, Guanhu St., Longhua District
Shenzhen,  CN 518000
Correspondent Contact Shengming Shi
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/19/2025
Decision Date 12/22/2025
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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