Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024512705

FEI Number

3024512705

Entity Name

Remote Smart Health LLC

City/State/Country

Daytona Beach, FL, US

Establishment Address

2441 Bellevue Ave, Daytona Beach, FL 32114, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Remote Smart Health LLC (Owner Number: 10086044)

Owner / Operator Contact Address

124 Lake Grove Road, Simpsonville, SC 29681, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111456

PMA Number

N/A

All Registered Proprietary Names

KismeTruth Remote Patient Monitoring Empirical Health Systems Clovis AI RPM Smarthealth1on1 Sunvision Medical KismeTruth Remote Patient Monitoring Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff Remote Smart Health-Smart Bluetooth Corded Arm Blood Pressure Monitor Large Cuff Cloviis AI RPM- Smart Bluetooth Corded Arm Blood Pressure Monitor-Large Cuff KismeTruth Remote Patient Monitoring Sunvision Medical Clovis AI RPM Smarthealth1on1 Test n Share Clovis AI RPM Smarthealth1on1 KismeTruth Remote Patient Monitoring Sunvision Medical Smart Diabetes Bluetooth Blood Glucose Monitoring System Test n Share Blood Glucose Monitoring System Smart Diabetes V Blood Glucose Monitoring System Smart Diabetes Blood Glucose Monitoring System Smarthealth1on1 Blood Glucose Monitoring System

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	2026-03-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-03-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2026-03-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-03-26
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2026-03-26

Official Correspondent

Victor Trani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Remote Smart Health LLC

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

Similar Registrations

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3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024512705. Last updated year: 2026. Please use registration number 3024512705 when referencing this establishment in official correspondence.