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510(k) Data Aggregation
K Number
K222420Device Name
Disposable Blood Pressure Cuff
Manufacturer
Wenzhou Xikang Medical Instruments Co., Ltd.
Date Cleared
2022-11-21
(102 days)
Product Code
DXQ, DXO
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Wenzhou Xikang Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Device Description
The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The device is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
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K Number
K212416Device Name
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
Manufacturer
Wenzhou Xikang Medical Instruments Co., Ltd
Date Cleared
2022-05-18
(288 days)
Product Code
DXQ, LDE
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Wenzhou Xikang Medical Instruments Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WX non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model. The device is applicable to all patients at least 2 years of age.
Device Description
WX non-Automated Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL WX02, WX0201, WX0202, WX0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model WX0201, WX0202, WX0203 include additional stethoscope (Single head, Dual head, and Sprague Rappaport). It is conjunction with Stethoscope when use.
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