Shoulder Pacemaker device SPM01M1

GUDID 08051122040902

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.

NCS LAB SRL

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• Primary Device ID: 08051122040902
• NIH Device Record Key: 8fb8f02f-3f33-464c-82a4-db87baecc79a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Pacemaker device
• Version Model Number: SPM01M1
• Catalog Number: SPM01M1
• Company DUNS: 429763668
• Company Name: NCS LAB SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051122040902 [Primary]

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-29
• Device Publish Date: 2021-09-01

Devices Manufactured by NCS LAB SRL

• 08051122040902 - Shoulder Pacemaker device: 2022-11-29The 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.
• 08051122040902 - Shoulder Pacemaker device: 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c
• 08051122040919 - Shoulder Pacemaker device (wireless PC): 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c
• 08051122040926 - MySPM App: 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the
• 08051122040933 - MySPM@Home App: 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of
• 08051122040940 - Stand-alone mode Kit: 2022-11-29 For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 confi
• 08051122040957 - Wireless mode - Kit: 2022-11-29 For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc
• 08051122040964 - Wireless app mode - Kit: 2022-11-29 For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SP
• 08051122040971 - Wireless app home mode - Kit: 2022-11-29 For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a ho