Identity
- Trade Name
- STM9000 FAST FDA UDI
- Generic Name
- Magnetic neural stimulation system, stationary FDA UDI
- Device Name
- Magnetic neural stimulation equipment. (Power supply voltage: 115VAC). FDA UDI
- Model / Reference
- B9700086240 FDA UDI
- Description
- Magnetic neural stimulation equipment. (Power supply voltage: 115VAC). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900536 FDA UDI
- 510(k) Number
- K150220 FDA UDI
- FDA Product Code
- GWF FDA UDI
- GMDN Term
- Magnetic neural stimulation system, stationary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Magnetic neural stimulation system, stationary
Stm9000 Fast by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Magnetic neural stimulation system, stationary.
- Magstim Double 70mm Air Cooled Coil — The Magstim Company , Ltd. · Class II
- Magstim Rapid² Power Supply Dual Module 115V — The Magstim Company , Ltd. · Class II
- Magstim Single 90mm Standard Coil — The Magstim Company , Ltd. · Class II
- Magstim Rapid² Power Supply Single Module 115V — The Magstim Company , Ltd. · Class II
- HORIZON™ 230V US Mains Filter — The Magstim Company , Ltd. · Class II
- Magstim Rapid² Mains Lead Filter 115V — The Magstim Company , Ltd. · Class II
- STM9000 FAST_BI — EB NEURO SPA · Class II
- STM9000 STANDARD_BI — EB NEURO SPA · Class II
Cleared under the same submission
K150220 also covers:
- Butterfly Coil 70 mm — EB NEURO SPA
- Butterfly Coil 70 mm air cooled — EB NEURO SPA
- Butterfly Coil 80 mm, 120° — EB NEURO SPA
- Circular Coil 70 mm — EB NEURO SPA
- Circular Coil 90 mm — EB NEURO SPA
- Circular Coil 90 mm air cooled — EB NEURO SPA
- STM9000 BASIC — EB NEURO SPA
- STM9000 BASIC — EB NEURO SPA
- STM9000 BASIC — EB NEURO SPA
- STM9000 BASIC — EB NEURO SPA
- STM9000 FAST — EB NEURO SPA
- STM9000 FAST — EB NEURO SPA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eb Neuro Spa
Sources (1)
- FDA UDI e85bd880-4a78-44c8-acc0-d1848b2c3f6b 35 fields · synced Jun 8, 2026