BIOTRICITY

FDA Device Registration & Listing · Redwood City, CA, US · Registration 3014235520

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014235520
FEI Number
3014235520
Entity Name
BIOTRICITY
City/State/Country
Redwood City, CA, US
Establishment Address
203 Redwood Shores Pkwy, Suite 600, Redwood City, CA 94065, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Biotricity (Owner Number: 10056742)
Owner / Operator Contact Address
203 Redwood Shores Pkwy, Suite 600, Redwood City, CA 94065, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140681
PMA Number
N/A

All Registered Proprietary Names

Biocore Biokit BP Biocore Pro Bioflux Biokit TP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2022-02-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-02-10
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2018-01-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-02-10

Official Correspondent

Spencer LaDow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biotricity
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014235520. Last updated year: 2026. Please use registration number 3014235520 when referencing this establishment in official correspondence.
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