Data / Medical devices / United States / Softwave Tissue Regeneraton Technologies, LLC
Softwave Tissue Regeneraton Technologies, LLC: FDA-registered device maker in Alpharetta, GA, United States, 8 510(k) clearances
Softwave Tissue Regeneraton Technologies, LLC is registered with the FDA (registration 3006066512) in Alpharetta, GA, United States. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006066512
- Address
- 10000 Avalon Blvd Suite 720, Alpharetta, GA, United States, 30009
- Owner or operator
- TISSUE REGENERATION TECHNOLOGIES, LLC (9094965)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 9, 2011
- Registered through
- 2026
- Brand names listed
- Applicator OE0035 and OE0050, Applicator OP 155, Applicator OP 155S, ChiroGold, DERMAGOLD, DermaGold, DermaGold, OrthoGold, LithoGold and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2024 | K233937 | OW100S | PZL | Substantially Equivalent | Softwave/Trt, LLC | accessdata.fda.gov |
| September 1, 2023 | K231710 | OW100S | PZL | Substantially Equivalent | Softwave/Trt, LLC | accessdata.fda.gov |
| October 12, 2022 | K213120 | OW100S (model OW100S-US) | ISA | Substantially Equivalent | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | accessdata.fda.gov |
| May 5, 2021 | K210451 | OrthoGold 100 | ISA | Substantially Equivalent | Tissue Regeneration Technologies, LLC | accessdata.fda.gov |
| August 28, 2020 | K200926 | OrthoGold 100 | PZL | Substantially Equivalent | Tissue Regeneration Technologies, LLC | accessdata.fda.gov |
| November 26, 2019 | K191961 | OrthoGold | PZL | Substantially Equivalent | Tissue Regeneration Technologies | accessdata.fda.gov |
| December 21, 2018 | K182682 | OrthoGold 100 | ISA | Substantially Equivalent | Tissue Regeneration Technologies | accessdata.fda.gov |
| November 2, 2006 | K062081 | LITHOGOLD | LNS | Substantially Equivalent | Tissue Regeneration Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- All makers of Massager, Therapeutic, Electric
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
Updated July 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.