Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015195058

FEI Number

3015195058

Entity Name

PureWave Life LLC

City/State/Country

Boynton Beach, FL, US

Establishment Address

3497 High Ridge Rd, Boynton Beach, FL 33426, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PureWave Life LLC (Owner Number: 10059128)

Owner / Operator Contact Address

3497 High Ridge Road, Boynton Beach, FL 33426, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PureWave Ultra PureWave Travel PureWave PEMI VEMI PurWave VEMI PureWave Clinic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-02-27
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-12-03

Official Correspondent

Toni Goren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PureWave Life LLC

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 3015195058. Last updated year: 2026. Please use registration number 3015195058 when referencing this establishment in official correspondence.