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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K240843
Device Name GENESIS (MS-P02-GEN)
Applicant
Climbing Steps, Inc.
1130 E. 24th St.
Brooklyn,  NY  11210
Applicant Contact Barry Fink
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.5150
Classification Product Code
ILK  
Date Received03/27/2024
Decision Date 10/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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