FDA Registration Active 🇨🇳 China

Health Sense Upper Arm Blood Pressure Monitor

Reg #: 3013053058 · FEI: 3013053058 · Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1

Registration Details

Registration Name
JOYTECH HEALTHCARE CO.,LTD.
Registration Number
3013053058
FEI Number
3013053058
Status
Active
Expiry Year
2025
Initial Importer
No
Address
No.365, Wuzhou Road
City
Hangzhou Zhejiang
Country
CN

Regulatory Submissions

510(k) Number
K173024

Owner / Operator

Firm Name
JOYTECH HEALTHCARE CO. LTD.
Operator Number
10054061
Address
No.365, Wuzhou Road
City
Hangzhou
State
Zhejiang
Postal Code
311100
Country
CN
Correspondent
Yunhua Ren

Products

Device Name Product Code
System, Measurement, Blood-Pressure, Non-Invasive DXN

Proprietary Names

Health Sense Upper Arm Blood Pressure Monitor healthsmart Premium Series Upper Arm Blood Pressure Monitor Item: 04-655-001 Talking Sense Blood Pressure Monitor Maverick Blood Pressure Monitor MABIS Universal Arm Talking Blood Pressure Monitor Item: 04-650-001 healthsmart Select Series Upper Arm Blood Pressure Monitor Item: 04-645-001 healthsmart Standard Series Upper Arm Blood Pressure Monitor Item: 04-635-001

Establishment Types

Manufacture Medical Device