Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030476

FEI Number

1000601592

Entity Name

LODE B.V.

City/State/Country

GRONINGEN, NL

Establishment Address

ZERNIKEPARK 16, GRONINGEN 9747 AN, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LODE B.V. (Owner Number: 9019791)

Owner / Operator Contact Address

ZERNIKEPARK 16, --, GRONINGEN, NL-NOTA 9747 AN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060820

PMA Number

N/A

All Registered Proprietary Names

Valiant 2 cpet Valiant 2 cpet XL Katana sport Valiant 2 rehab XL Flow cpet Katana sport XL Valiant 2 sport XL Valiant 2 pediatric Valiant 2 sport Valiant 2 OEM Flow rehab Valiant 2 rehab Angio cpet - with electrical adjustable wall mount Angio rehab electrical wall fix. Corival Recumbent cpet Flow cpet Valiant 2 pediatric Valiant 2 rehab XL Angio imaging support ultrasound Excalibur Sport PFM Brachumera Sport Corival rehab Brachumera Sport PFM Valiant 2 sport XL Valiant 2 sport Angio rehab Angio imaging fixation set Angio cpet - single set Corival OEM Angio cpet - with static wall mount Angio rehab fixation set Corival Recumbent rehab Katana sport Katana sport XL Angio imaging support radiology Excalibur Sport Valiant 2 cpet XL Angio cpet - with automatic stand Corival Pediatric Valiant 2 OEM Corival cpet Flow rehab Valiant 2 rehab Valiant 2 cpet Angio rehab - static wall fixation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2021-11-12
IOL	Treadmill, Powered	Physical Medicine	Class 1	890.5380	2009-05-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-05-13
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2009-05-13

Official Correspondent

Jan Reinder Fransens

US Agent Details

Dana Burger-Dipzinski Business: ElectraMed Corporation Email: Dana@electramed.com Phone: (800) 6784856

Related Public Records

Same Entity

LODE B.V.

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.

Similar Registrations

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3025823131	SWORD HEALTH S.A.	Vila Nova de Gaia Porto, PT
3029303083	STRIDELINK INC.	Atlanta, GA, US
3012187972	BRIGHT CLOUD INTERNATIONAL CORP.	Elkton, FL, US
3041680548	XRHEALTH AMERICA INC	Needham, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030476. Last updated year: 2026. Please use registration number 8030476 when referencing this establishment in official correspondence.