WELLVII INC

FDA Device Registration & Listing · Palm Beach Gardens, FL, US · Registration 3037007069

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
3037007069
FEI Number
3037007069
Entity Name
WELLVII INC
City/State/Country
Palm Beach Gardens, FL, US
Establishment Address
4521 Pga Blvd, Pmb 341, Palm Beach Gardens, FL 33418, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Wellvii Inc (Owner Number: 10047727)
Owner / Operator Contact Address
4521 PGA Blvd, PMB 341, Palm Beach Gardens, FL 33418, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231625
PMA Number
N/A

All Registered Proprietary Names

VitalDetect

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 2025-03-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-03-19
DQA Oximeter Cardiovascular Class 2 870.2700 2025-03-19

Official Correspondent

Mark Khachaturian

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wellvii 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.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037007069. Last updated year: 2026. Please use registration number 3037007069 when referencing this establishment in official correspondence.
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