FDA Clearance & Compliance

FDA 510(k) Clearance

510(k) Number

K182018

Device Name

Bluetooth Blood Pressure Monitor (BPW1)

Regulation Number

21 CFR 870.1130

Regulation Name

Noninvasive Blood Pressure Measurement System

Regulatory Class

Class II

Product Code

DXN

Type of Use

Over-the-Counter (21 CFR 801, Subpart C)

Clearance Date

October 6, 2018

Issued By

U.S. Food & Drug Administration, Center for Devices and Radiological Health

Indications for Use

“This blood pressure monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm–21.5cm.”

Scope of Clearance

Vital Buddy's blood pressure and heart rate monitoring functions are based on the FDA-cleared 510(k) device identified above. This clearance applies only to those specific monitoring functions and their stated indications for use.

Other Vital Buddy features — including SpO2, temperature, sleep, and activity tracking — are not part of this FDA clearance, are not FDA-cleared, and are not intended for medical use.

FDA Clearance Letter

The complete FDA 510(k) clearance letter is provided below.

VitalFriend's Relationship with Kingyield

VitalFriend, Inc. is the exclusive global distributor for the BPW1 and other products developed in partnership with Shenzhen Kingyield Technology Co., Ltd.