BTL Industries, Inc.
FDA 510(k) & PMA Approved Devices — 34 products
Total Devices34
Categories13
Latest FDA decision2026-06-12
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K211107 | BTL-899 FP | GEI | 2021-07-09 | View |
| 510(k) | K190456 | BTL 799-2L | NGX | 2019-07-05 | View |
| 510(k) | K190023 | BTL-084 | PBX | 2019-03-29 | View |
| 510(k) | K182363 | BTL-703 | IMJ | 2019-01-24 | View |
| 510(k) | K180359 | BTL-FR2000 | GEI | 2018-12-13 | View |
| 510(k) | K181497 | HPM-6000UF | KPI | 2018-11-14 | View |
| 510(k) | K182106 | BTL 799-2T | NGX | 2018-10-23 | View |
| 510(k) | K180813 | BTL 799-2 | NGX | 2018-06-14 | View |
| 510(k) | K163165 | AM-100 | NGX | 2017-02-16 | View |
| 510(k) | K163176 | Exilis XP II | PBX | 2017-01-12 | View |
| 510(k) | K162010 | HPM-6000U | KPI | 2016-12-13 | View |
| 510(k) | K160992 | HPM-6000 | IPF | 2016-10-21 | View |
| 510(k) | K161551 | TR-100 | PBX | 2016-09-13 | View |
| 510(k) | K152731 | XP1100 RF | GEI | 2016-07-20 | View |
No matching devices.
Page 2 of 2
Related Clinical Trials
NCT07624539Device for Alleviating Temporomandibular Joint (TMJ) PainCOMPLETEDNCT07661082Safety and Efficacy of the BTL-043 Device in Alleviating Back PainCOMPLETEDNCT07661121EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain ReliefACTIVE_NOT_RECRUITINGNCT07679750rTMS Device for Improvement of Obsessive and Compulsive BehaviorsNOT_YET_RECRUITINGNCT07698639Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke RehabilitationCOMPLETEDNCT07700433Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back PainACTIVE_NOT_RECRUITINGNCT07737184Vacuum Compression Therapy for Chronic Lower Limb UlcersCOMPLETED