Stand-alone mode Kit SPM01K1

GUDID 08051122040940

For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes, and protective skin.

NCS LAB SRL

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08051122040940
• NIH Device Record Key: 80353165-de37-470a-be09-de43e5ca02ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stand-alone mode Kit
• Version Model Number: SPM01K1
• Catalog Number: SPM01K1
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	08051122040940 [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

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• 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: 2022-11-29For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes, and protective skin.
• 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