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JOYTECH Healthcare Co., Ltd. FDA Approvals

0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
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)510(k)Aug 26, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 26, 2026
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)510(k)Aug 13, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 13, 2026
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)510(k)Apr 28, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 28, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)510(k)Feb 13, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 13, 2026
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)510(k)Jul 2, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 2, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)510(k)Jun 26, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)510(k)Jan 13, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 13, 2025
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)510(k)Dec 19, 2024Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Dec 19, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor510(k)Jan 26, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor510(k)Aug 25, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 25, 2023
Wrist-type Fully Automatic Digital Blood Pressure Monitor510(k)Mar 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 1, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor510(k)Jan 5, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 5, 2022

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