Identity
- Trade Name
- SPINE KIT – 2 WISE FDA UDI
- Generic Name
- Kinesiology/electromyographic sensor set FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SHWM01S2 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051122041077 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Kinesiology/electromyographic sensor set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Kinesiology/electromyographic sensor set
Spine Kit – 2 Wise 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 7bebdb17-e6c8-454f-892a-75e8d6863eee 34 fields · synced Jun 6, 2026