Home / 510(k) Clearances / K213189

510(k) K213189

Wrist-type Fully Automatic Digital Blood Pressure Monitor by Joytech Healthcare Co. , Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
September 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Joytech Healthcare Co. , Ltd.

  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (June 26, 2025)
  • K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, D (January 13, 2025)
  • K241322 — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (December 19, 2024)
  • K231303 — Arm-type Fully Automatic Digital Blood Pressure Monitor (January 26, 2024)
  • K230566 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automa (August 25, 2023)
  • K212115 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automa (January 5, 2022)
  • K200649 — Arm-Type Fully Automatic Digital Blood Pressure Monitor (August 3, 2020)
  • K200599 — Digital Thermometer (July 8, 2020)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)