Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005998761

FEI Number

3005998761

Entity Name

BTS SPA

City/State/Country

VIGONZA Padova, IT

Establishment Address

VIA CAPRICCIO 3/A, VIGONZA Padova 35010, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BTS S.p.A. (Owner Number: 9091843)

Owner / Operator Contact Address

VIA CAPRICCIO 3/A, --, VIGONZA, IT-PD 35010, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131660

PMA Number

N/A

All Registered Proprietary Names

baiobit TMJOINT FREEEMG 1000 OMNIsEMG G-Sensor 2 NIRVANA P6000 P4000 SMART-DX SMART-DX EVO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2006-09-01
KHX	Platform, Force-Measuring	Physical Medicine	Class 1	890.1575	2013-03-27
LXJ	Interactive Rehabilitation Exercise Devices	Physical Medicine	Class 2	890.5360	2014-05-06

Official Correspondent

BRUNO ROS

US Agent Details

Christian Costantini Business: MACLIN POWER INC. Email: sales@maclinmed.com Phone: (786) 8187337

Related Public Records

Same Entity

BTS S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005998761. Last updated year: 2026. Please use registration number 3005998761 when referencing this establishment in official correspondence.