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Shoulder Pacemaker device (wireless PC)
FDA UDIClass II (US FDA UDI)
by Ncs Lab Srl
Identity
- Trade Name
- Shoulder Pacemaker device (wireless PC) FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SPM01M2 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SPM01M2 FDA UDI
- Primary DI / UDI-DI
- 08051122040919 FDA UDI
- FDA Product Code
- IPF FDA UDIKQX FDA UDIHCC FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI888.1500 FDA UDI882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Shoulder Pacemaker device (wireless PC) by Ncs Lab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ncs Lab Srl
Sources (1)
- FDA UDI 0a860ab7-8bdf-4e89-b72b-be341147a7be 34 fields · synced May 30, 2026