BODYTRACE

FDA Device Registration & Listing · San Jose, CA, US · Registration 3011912849

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
3011912849
FEI Number
3011912849
Entity Name
BODYTRACE
City/State/Country
San Jose, CA, US
Establishment Address
2150 N. First St, Unit 469, San Jose, CA 95131, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BODYTRACE, INC. (Owner Number: 10054678)
Owner / Operator Contact Address
2150 N. First St, Unit 469, San Jose, CA 95131, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K190507
PMA Number
N/A

All Registered Proprietary Names

BT108B BT108A

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-04-20

Official Correspondent

AMIT GHIA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BODYTRACE, INC.
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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3019575688 AKTIIA SA Neuchatel, CH
3010222749 SEERS CO., LTD. Pyeongtaek Gyeonggi, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011912849. Last updated year: 2026. Please use registration number 3011912849 when referencing this establishment in official correspondence.
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