Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005655081

FEI Number

3005655081

Entity Name

HealthTronics, LLC

City/State/Country

Round Rock, TX, US

Establishment Address

1990 Steam Way, Suite A 102, Round Rock, TX 78665, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HealthTronics, LLC (Owner Number: 10058145)

Owner / Operator Contact Address

1990 Steam Way, Suite A 102, Round Rock, TX 78665, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021775

PMA Number

N/A

All Registered Proprietary Names

LithoDiamond

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2018-07-24

Official Correspondent

David Furr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HealthTronics, 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 3005655081. Last updated year: 2026. Please use registration number 3005655081 when referencing this establishment in official correspondence.