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spECTrum

FDA UDI

Class III (US FDA UDI)

by Mecta Llc

Identity

Trade Name
spECTrum FDA UDI
Generic Name
Electroconvulsive therapy system FDA UDI
Device Name
100 Joule ECT Device with 4 Parameter Setting Controls FDA UDI
Model / Reference
4000DQ FDA UDI
Description
100 Joule ECT Device with 4 Parameter Setting Controls FDA UDI

Identifiers

Primary DI / UDI-DI
00861539000127 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
MRI Safety
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

K965070 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mecta Llc

Sources (1)

  • FDA UDI 548da6d9-d042-4c33-bbd4-f0c5cccc57fe 35 fields · synced May 31, 2026