Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006066512

FEI Number

3006066512

Entity Name

SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC

City/State/Country

Alpharetta, GA, US

Establishment Address

10000 Avalon Blvd, Suite 720, Alpharetta, GA 30009, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TISSUE REGENERATION TECHNOLOGIES, LLC (Owner Number: 9094965)

Owner / Operator Contact Address

10000 Avalon Blvd, Suite 720, Alpharetta, GA 30009, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182682

PMA Number

N/A

All Registered Proprietary Names

Viasure Applicator OP 155 SoftWave OrthoGold 100 Applicator OP 155S OW100S UroGold OrthoGold Applicator OE0035 and OE0050 Applicator OP 155 DermaGold DermaGold, OrthoGold Applicator OP 155 OW100S, OrthoGold, DermaGold Applicator OP 155S SoftWave Gold Li SoftWave Gold ChiroGold DermaGold, OrthoGold Applicator OP 155

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	2021-05-13
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	Class 2	878.4685	2023-11-01
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2011-08-09
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	Class 2	878.4685	2020-05-22
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-03-14
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-05-22

Official Correspondent

John Warlick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TISSUE REGENERATION TECHNOLOGIES, 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 3006066512. Last updated year: 2026. Please use registration number 3006066512 when referencing this establishment in official correspondence.