Joytech Healthcare Co. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus), Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P), Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Joytech Healthcare Co. , Ltd. Cardiovascular ✕
14 devices
Cleared
Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
Cardiovascular
119d
Cleared
Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
Cardiovascular
316d
Cleared
Apr 28, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B,...
Cardiovascular
263d
Cleared
Feb 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L,...
Cardiovascular
171d
Cleared
Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
Cardiovascular
121d
Cleared
Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
Cardiovascular
237d
Cleared
Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor
Cardiovascular
266d
Cleared
Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
Cardiovascular
177d
Cleared
Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
Cardiovascular
153d
Cleared
Jan 05, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
Cardiovascular
182d
Cleared
Aug 03, 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
Cardiovascular
144d
Cleared
Jul 29, 2019
Non-invasive blood pressure measurement systems
Cardiovascular
116d
Cleared
Aug 22, 2018
Non-invasive blood pressure measurement systems
Cardiovascular
328d
Cleared
Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
Cardiovascular
261d