Identity
- Trade Name
- MySPM@Home App FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SPM01A2 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SPM01A2 FDA UDI
- Primary DI / UDI-DI
- 08051122040933 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
MySPM@Home App 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 b7d7b616-ec3e-41a2-a6ae-74bc6dc7c7f6 34 fields · synced May 30, 2026