Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012563838

FEI Number

3012563838

Entity Name

Impulse Dynamics USA Inc

City/State/Country

Marlton, NJ, US

Establishment Address

50 Lake Center Executive Parkway, Suite 100, 401 Route 73 N, Bldg. 50, Marlton, NJ 08053, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Impulse Dynamics USA Inc (Owner Number: 10032587)

Owner / Operator Contact Address

50 Lake Center Executive Parkway, 401 Route 73 N, Bldg. 50, Suite 100, Marlton, NJ 08053, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P180036

All Registered Proprietary Names

OPTIMIZER Smart System OPTIMIZER Smart Mini System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFV	Implantable Pulse Generator	Unknown	Class 3	N/A	2019-03-25

Official Correspondent

Lawrence Picciano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Impulse Dynamics USA Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012563838. Last updated year: 2026. Please use registration number 3012563838 when referencing this establishment in official correspondence.