Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030977408

FEI Number

3030977408

Entity Name

SHOCKWAVE CENTERS OF AMERICA

City/State/Country

Marietta, GA, US

Establishment Address

2874 Johnson Ferry Rd Ste 100, Marietta, GA 30062, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Shockwave Centers of America (Owner Number: 10090587)

Owner / Operator Contact Address

4880 Lower Roswell road, Suite 20, Marietta, GA 30068, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mark 111 Radial Mark V OTG Mark VI FocusWave Wasabi Whole Body Upgrade System

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	2024-04-16

Official Correspondent

Daniel Ruitenbeek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shockwave Centers of America

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 3030977408. Last updated year: 2026. Please use registration number 3030977408 when referencing this establishment in official correspondence.