FDA.reportPublic FDA data

510(k) K240959

Device
Respiratory Muscle Trainer
Applicant
Chongqing Moffy Innovation Technology Co., Ltd.
510(k) number
K240959
Product code
BYI
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-04-08
Regulation
868.5665
Classification name
Percussor, Powered-Electric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Yongxu Li
Address
#292 Jingdongfang Rd. Beibei Dist Chongqing CN 400714 400714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K132794SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.2013-12-19
K121587BREATH SHAKECheen Houng Ent. Co. , Ltd.2013-11-22
K122480INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation2013-03-27
K121170RESIN 11Respinnovation Sas2012-07-13
K103176FREQUENCERDymedso, Inc.2011-01-26