Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016018167

FEI Number

3016018167

Entity Name

DAVID HEALTH SOLUTIONS, LTD.

City/State/Country

Outokumpu Pohjois-Karjala, FI

Establishment Address

Tutkijankatu 2, Outokumpu Pohjois-Karjala 83500, FI

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

David Health Solutions, Ltd. (Owner Number: 10078834)

Owner / Operator Contact Address

Tutkijankatu 2, Outokumpu, FI-13 83500, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G-510E Scapula Protraction/Chest Press 2.5 / 100 kg (5.5 / 220 lbs) G200E Knee Extension 2.5 / 5 / 150 kg (5.5 / 11 / 330 lbs) EVE WEB Additional Exercises Module G310A Hip Abduction, DMS-EVE, 2,5 / 100 kg, automatic EVE WEB Calendar Modul (Excludes On-Line booking) G420A Lateral Pulldown DMS-EVE 2,5 / 100kg, automatic EVE Professional Terminal (Integrated, For EVE capable machines) EVE WEB Software Service (1-year license) Premium EVE WEB Software Service (1-year license) Basic EVE Printer rack for Info-Kiosk G-150E Lumb./Thorac. Lat. Flexion 2.5 / 100 kg (5.5 / 220 lbs) G-660E Glenohumeral External Rotation 2.5 / 100 kg (5.5 / 220 lbs) G-160E Cervical Rotation 1 / 25 kg (2.2 / 55 lbs) G-140E Cerv. Extens./Lat. Flexion 1 / 25 kg (2.2 / 55 lbs) EVE WEB Software (Startup Fee) Basic DAVID G310M Hip Abduction 2.5 / 100 kg (5.5 / 220 lbs) G-120E Lumb./Thorac. Rotation 2.5 / 100 kG- (5.5 / 220 lbs) G200A Knee Extension, DMS-EVE. 2,5 / 5 / 150 kg, automatic G150A Lumb./Thorac. Lat. Flex., DMS-EVE, 2,5 / 100kg, automatic EVE WEB Software Service (1-year license) Enterprise EVE WEB Questionnaire Module Exercise Terminal floor mounted G300A Knee Flexion, DMS-EVE, 2,5 / 5 / 150 kg, automatic Exercise Kiosk 42 inch (Floor mounted LCD sccreen)) G250E Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg G120A Lumb./Thorac. Rotation, DMS-EVE, 2,5 / 100kg, automatic G250A Elliptic Leg Press, DMS-EVE. 2,5 / 5 / 150 kg, automatic EVE Info-Kiosk Central Server with keyboard stand (needs a connection package) G640A Glenohumeral Internal Rotation, DMS-EVE 2,5 / 100kg, automatic EVE Terminal Upgrade (requires return of defect terminal) API Annual Connection fee each additional center - Tier 2 EVE Professional Terminal (Upgrade, includes stands, harware, etc.) G160A Cervical Rotation, DMS-EVE, 1 / 25kg, automatic G140A Cerv. Extens./Lat. Flexion, DMS-EVE, 1 / 25kg, automatic G320A Hip Adduction, DMS-EVE, 2,5 / 100 kg, automatic EVE WIRELESS Connection Package EVE Info-Kiosk Central Server (with a keyboard stand) EVE WEB Software (Startup Fee) Enterprise G300E Knee Flexion 2.5 / 5 / 150 kg (5.5 / 11 / 330 lbs) G-420E Lateral Pulldown 2.5 / 100 kg (5.5 / 220 lbs) G260 Hip Extension 2.5 / 100 kg (5.5 / 220 lbs) G460A Diagonal Shoulder Abduction, DMS-EVE 2,5 / 100kg, automatic G-640E Glenohumeral Internal Rotation 2.5 / 100 kg (5.5 / 220 lbs) G110A Lumb./Thorac. Extension, DMS-EVE, 2,5 / 100kg, automatic G-110E Lumb./Thorac. Extension 2.5 / 100 kG- (5.5 / 220 lbs) G660A Glenohumeral External Rotation, DMS-EVE 2,5 / 100kg, automatic G320M Hip Adduction 2.5 / 100 kg (5.5 / 220 lbs) G130A Lumb./Thorac. Flexion, DMS-EVE, 2,5 / 100kg, automatic API Annual Connection fee for one center - Tier 2 G-130E Lumb./Thorac. Flexion 2.5 / 100 kg (5.5 / 220 lbs) Exercise Kiosk 42 inch (Wall mounted LCD sccreen)) G510A Scapula Protraction/Chest Press DMS-EVE 2,5 / 100 kg automatic G260A Hip Extension DMS-EVE 2,5 / 100 kg, automatic EVE WEB Software (Startup Fee) Premium EVE WEB Software device fee (per device per year - required for all SAAS installations) G-460E Diagonal Shoulder Abduction 2.5 / 100 kg (5.5 / 220 lbs)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	Class 2	890.5360	2020-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

Matti Jarvinen Business: David Health. LLC Email: andy.jarvinen@davidhealth.com Phone: (720) 2017207

Related Public Records

Same Entity

David Health Solutions, Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3023132085	VIRTUSENSE	Peoria, IL, US
3038287494	RYMO TECHNOLOGIES PRIVATE LIMITED	Navi Mumbai Maharashtra, IN
3013517146	NeuroXtherapeutics SA	Lausanne Vaud, CH
3021826803	VERITY TECHNOLOGIES	Elmhurst, IL, US
3042285056	SHANGHAI ZDROID MEDICAL TECHNOLOGY CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016018167. Last updated year: 2026. Please use registration number 3016018167 when referencing this establishment in official correspondence.