Data / Medical devices / United States / Theragen, Inc.
Theragen, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 3 510(k) clearances and 1 PMA approval
Theragen, Inc. is registered with the FDA (registration 3013378804) in Jacksonville, FL, United States. It lists 5 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated December 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013378804
- Address
- 10151 Deerwood Park Blvd., Jacksonville, FL, United States, 32256
- Owner or operator
- Theragen Inc (10053378)
- Roles
- Specification developer
- First device listed
- November 29, 2016
- Registered through
- 2026
- Brand names listed
- ActaStim-S, Kneehab+ TENS, Neurotech Plus, Neurotech Recovery
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | 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 |
|---|---|---|---|---|---|---|
| January 20, 2012 | K112934 | NEUROTECH RECOVERY | GXY | Substantially Equivalent | Bio-Medical Research, Ltd. | accessdata.fda.gov |
| January 9, 2012 | K112258 | NEUROTECH PLUS | GZJ | Substantially Equivalent | Bio-Medical Research, Ltd. | accessdata.fda.gov |
| August 3, 2011 | K110350 | KNEEHAB XP | GZJ | Substantially Equivalent | Bio-Medical Research, Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 2020 | P190030 | ActaStim-S Spine Fusion Stimulator | LOF | 4 | May 13, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Bone Growth, Non-Invasive
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
Updated May 13, 2026. 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.