Identity
- Trade Name
- spECTrum FDA UDI
- Generic Name
- Electroconvulsive therapy system FDA UDI
- Device Name
- 100 Joule ECT Device with 4 Parameter Setting Controls and Patient Monitoring FDA UDI
- Model / Reference
- 5000DQ FDA UDI
- Description
- 100 Joule ECT Device with 4 Parameter Setting Controls and Patient Monitoring FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861539000103 FDA UDI
- 510(k) Number
- K965070 FDA UDI
- FDA Product Code
- GXC FDA UDI
- GMDN Term
- Electroconvulsive therapy system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 882.5940 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
No
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
MR Unsafe FDA UDI
Category: Electroconvulsive therapy system
spECTrum by Mecta Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroconvulsive therapy system.
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Mecta Llc
Sources (1)
- FDA UDI f65b3129-aafb-4660-aeb0-31ce90dd9746 35 fields · synced Jun 8, 2026