Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038429246

FEI Number

3038429246

Entity Name

EPTAM PRECISION MOLDING MA (A DIVISION OF EPTAM PRECISION)

City/State/Country

Lancaster, MA, US

Establishment Address

640 Sterling Street, Lancaster, MA 01523, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EPTAM Precision Molding MA (a Division of EPTAM Precision) (Owner Number: 10093450)

Owner / Operator Contact Address

640 Sterling Street, Lancaster, MA 01523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Treatment System (VHT-200) Patient Magnet Patient Magnet Patient Magnet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2025-07-31
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Unknown	Class 3	N/A	2025-05-16
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2025-05-16
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2025-05-16
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2025-05-16
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2025-05-16
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2025-05-16

Official Correspondent

Emmanuel Nyakako

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPTAM Precision Molding MA (a Division of EPTAM Precision)

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2367-2024	Abbott Medical	3	Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Z-0023-2018	St. Jude Medical, Inc.	3	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Z-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-2265-2024	Abbott Medical	3	Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

Similar Registrations

Registration Number	Establishment Name	Location
3005144609	EPTAM PLASTICS, LTD	Northfield, NH, US
3006538358	AOTI LTD.	GALWAY, IE
3008847017	GWR MEDICAL, INC.	Chadds Ford, PA, US
3008139322	ELECTROCHEMICAL OXYGEN CONCEPTS	San Antonio, TX, US
3004727093	IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.	Reynosa Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038429246. Last updated year: 2026. Please use registration number 3038429246 when referencing this establishment in official correspondence.