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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K213000
Device Name Air Compression Massager (Model LF-FT003)
Applicant
Wenzhou Lingfeng Electronic Technology Co., Ltd.
#9,Jintang Rd.,Jielu Industry District,Bishan Town
Ruian,  CN 325200
Applicant Contact Xiaoqun Ye
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/20/2021
Decision Date 11/15/2021
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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