XTREEM PULSE

FDA Device Registration & Listing · New York, NY, US · Registration 3012470925

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012470925
FEI Number
3012470925
Entity Name
XTREEM PULSE
City/State/Country
New York, NY, US
Establishment Address
690 Washington St, # 4B, New York, NY 10014, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
XTREEM PULSE (Owner Number: 10057865)
Owner / Operator Contact Address
690 Washington Street, 4B, New York, NY 10014, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221443
PMA Number
N/A

All Registered Proprietary Names

Pure Flow PureLift PureLift PRO PureLift Pro Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRN Device, Counter-Pulsating, External Cardiovascular Class 2 870.5225 2018-06-05
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Neurology Class 2 882.5890 2019-12-24
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Neurology Class 2 882.5890 2022-12-28

Official Correspondent

Andrew Barile

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XTREEM PULSE
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 3012470925. Last updated year: 2026. Please use registration number 3012470925 when referencing this establishment in official correspondence.
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