Shoulder PacemakerTM
NCS Lab Srl
NCS LAB SRL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011410128 | 3011410128 | NCS LAB SRL | 1 | N | 2026-01-01 | Via Pola Esterna 4/12 Carpi Modena IT 41012 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 186905 | 1703056844 | K220994 | Shoulder PacemakerTM | IPF | 2022-10-14 |
| 186905 | 1313489564 | K210674 | Shoulder Pacemaker | IPF | 2021-08-24 |
| 186905 | 1490297096 | K160500 | Elite SPK, Compasso, Elite SPK Kit | MBI | 2016-04-20 |
| 186905 | 1834816741 | K120356 | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD | MBI | 2012-12-11 |
| 186905 | 1251273988 | ||||
| 186905 | 1929722510 |
Product Codes Associated With Registrations#
PMN#
Shoulder Pacemaker
Ncs Lab Srl
Elite SPK, Compasso, Elite SPK Kit
NCS Lab Srl
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
NCS LAB SRL
GUDID#
Elite Spk inserter - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
GT TUNNELER - GT TUNNELER is a sterile, single-use device used in standard shoulder arthroscopy procedures.
2022-06-03
Software web Showmotion - Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.
2022-03-14
Shoulder Pacemaker device - The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it.The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional.
2021-09-01
Shoulder Pacemaker device (wireless PC) - The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M2 configuration supports IEEE 802.15.4 radio interface. In this case it provides for the exchange of data between the stimulator and a receiver connected to the PC, which then collects the data sent by the device and synchronizes the transmission. The dedicated control software is supplied via an usb receiver.
2021-09-01
MySPM App - Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
2021-09-01
MySPM@Home App - Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
2021-09-01
Stand-alone mode Kit - For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes, and protective skin.
2021-09-01
Wireless mode - Kit - For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc/laptop, the content of the SPM01K2 convenience kit is: 1 electrostimulator SPM01M2 configuration; electrodes, and protective skin.
2021-09-01
Wireless app mode - Kit - For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
2021-09-01
Wireless app home mode - Kit - For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM@Home mobile application (SPM01A2).
2021-09-01
Taylor Stitcher Sterilization basket - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
TAYLOR STITCHER - Complete set of surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher body - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Punch - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Screwdriver - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Targeting system - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Screw ring main body - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Screws - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Hammer - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Spanner 7mm - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
Taylor Stitcher Cannula - Surgical instrument to be used with Superelastic Transosseous Needle (STN).
2022-06-09
GT TUNNELER KIT - GT TUNNELER device and non-adsorbable sutures.
2022-06-03
WISE (wireless inertial sensor equipment) - The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes and magnetometers.
2022-03-14
Gateway - The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inertial sensor.
2022-03-14
UPPER LIMB KIT – 5 WISE - The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district.
2022-03-14
UPPER LIMB KIT – 7 WISE - The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district.
2022-03-14
LOWER LIMB KIT – 6 WISE - The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district.
2022-03-14
LOWER LIMB KIT – 8 WISE - The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district.
2022-03-14
TOTAL BODY KIT – 12 WISE - The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the total body.
2022-03-14
SPINE KIT – 2 WISE - The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine.
2022-03-14
SPINE KIT – 3 WISE - The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine and the head.
2022-03-14
Elite SPK Kit - The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form
2016-12-23