Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003695829

FEI Number

3003695829

Entity Name

OnCore Manufacturing

City/State/Country

Westborough, MA, US

Establishment Address

125 Fisher Street, Westborough, MA 01581, US

Establishment Type(s)

Remanufacture Medical Device

Owner / Operator

OnCore Manufacturing LLC (Owner Number: 10050743)

Owner / Operator Contact Address

125 Fisher Street, Westborough, MA 01581, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Impedimed SOZO Pro Impedimed SOZO Pro Impedimed SOZO Podimetrics Remote Temperature Monitoring System SmartMat (SKU PMHS201U-R) Podimetrics Remanufactured SmartMat (SKU PMHS201U) SmartMat (SKU PMHS201U) Podimetrics Wi-Fi SmartMat (SKU PMHS230U) Podimetrics SmartMat+ (SKU PMHS300U) Impedimed SOZO Impedimed SOZO Podimetrics SmartMat (SKU PMHS201U)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-01-28
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2024-01-28
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-01-28
QJB	Adjunct Monitor, Protein Calorie Malnutrition	Cardiovascular	Class 2	870.2770	2024-01-28
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-01-28
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	Class 1	890.5050	2019-06-26
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2024-01-28
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2024-01-28
QJB	Adjunct Monitor, Protein Calorie Malnutrition	Cardiovascular	Class 2	870.2770	2024-01-28
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	Class 2	870.2770	2024-01-28
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	Class 1	890.5050	2021-06-11

Official Correspondent

John Marcil

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3004782476	Impedimed Limited	Lindfield New South Wales, AU
3007305624	GUANGDONG BIOLIGHT MEDITECH CO., LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003695829. Last updated year: 2026. Please use registration number 3003695829 when referencing this establishment in official correspondence.