Data / Medical devices / Italy / BTS SPA
BTS SPA: FDA-registered device maker in VIGONZA Padova, Italy, 2 510(k) clearances
BTS SPA is registered with the FDA (registration 3005998761) in VIGONZA Padova, Italy. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005998761
- Address
- Via Capriccio 3/A, VIGONZA Padova, Italy, 35010
- Owner or operator
- BTS S.p.A. (9091843)
- Roles
- Manufacturer
- First device listed
- September 1, 2006
- Registered through
- 2026
- Brand names listed
- FREEEMG 1000, G-Sensor 2, NIRVANA, OMNIsEMG, P4000, P6000, SMART-DX, SMART-DX EVO and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Device, Muscle Monitoring | KZM | 2 | Manufacturer | accessdata.fda.gov |
| Interactive Rehabilitation Exercise Devices | LXJ | 2 | Manufacturer | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 21, 2016 | K161716 | TEETHAN 2.0 | KZM | Substantially Equivalent | Bts S.P.A. | accessdata.fda.gov |
| April 17, 2014 | K131660 | SMART (SMART-D, SMART-DX) | LXJ | Substantially Equivalent | Bts S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Muscle Monitoring
- All makers of Platform, Force-Measuring
- All makers of Device, Biofeedback
- All makers of Interactive Rehabilitation Exercise Devices
Updated December 21, 2016. 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.