Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948217

FEI Number

3006948217

Entity Name

BODYSTAT LTD

City/State/Country

Isle of Man, IM

Establishment Address

Chester House, Main Road, Sulby, Isle of Man IM7 2HJ, IM

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BodyStat Ltd (Owner Number: 10024885)

Owner / Operator Contact Address

Chester House, Main Road, Sulby, IM-NOTA IM7 2HJ, IM

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082253

PMA Number

N/A

All Registered Proprietary Names

Bodystat 1000 Bodystat 500 QuadScan 4000 Bodystat MultiScan 5000 Bodystat 1500MDD Bodystat 1500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2015-11-27
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2013-01-21
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2014-06-27
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2013-01-21
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2009-01-06

Official Correspondent

Karen Oakes

US Agent Details

Richard Wynkoop Business: Vision28 Email: rich@vision28.com Phone: (541) 6049654

Related Public Records

Same Entity

BodyStat Ltd

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
K994242	Bodystat , Ltd.	BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT	2000-03-15

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3012094189	BIOTEKNA SRL	Marcon Veneto, IT
3007695022	Guangdong Winburg Technology Co.,Ltd	ZHONGSHAN Guangdong, CN
3006624940	SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948217. Last updated year: 2026. Please use registration number 3006948217 when referencing this establishment in official correspondence.