Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012604011

FEI Number

3012604011

Entity Name

PROFOUND MEDICAL INC.

City/State/Country

Mississauga Ontario, CA

Establishment Address

2400 Skymark Avenue, Unit 6, Mississauga Ontario L4W 5K5, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Profound Medical Inc. (Owner Number: 10061262)

Owner / Operator Contact Address

2400 Skymark Avenue, Unit 6, Mississauga, CA-ON L4W 5K5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240296

PMA Number

N/A

All Registered Proprietary Names

TULSA-PRO TULSA-PRO TULSA-PRO TULSA-PRO Sonalleve MR-HIFU TULSA-PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2022-09-08
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2019-10-03
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2023-10-06
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2020-09-17
QND	N/A	N/A	Class N/A	N/A	2021-06-25
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Gastroenterology, Urology	Class 2	876.4340	2024-05-15

Official Correspondent

Imen Ferchichi

US Agent Details

Arun Menawat Email: amenawat@profoundmedical.com Phone: (239) 3169146

Related Public Records

Same Entity

Profound Medical 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 3012604011. Last updated year: 2026. Please use registration number 3012604011 when referencing this establishment in official correspondence.