Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M
FDA 510(k)Class II (US FDA 510(k))
by Mecta Corp.
Identifiers
- 510(k) Number
- K960754 FDA 510(k)
- FDA Product Code
- QGH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5940 FDA 510(k)
- Regulation Number
- 882.5940 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spectrum 5000 Q, 5000 M, 4000 Q, and 4000 M are Electroconvulsive Therapy Devices designed to induce therapeutic seizures for the treatment of catatonia, major depressive disorder, and bipolar disorder. These devices deliver constant-current, bi-directional square waveform electrical stimuli to facilitate clinical outcomes in controlled medical settings.
Used in hospital suites, operating rooms, or wards, these devices are operated by clinicians. The 5000 Q and 4000 Q models provide adjustable stimulus parameters for energy and charge, while the 5000 M and 4000 M feature a single Stimulus Intensity knob for simplified operation. They are classified as Class II devices under FDA regulations, with a 510(k) clearance (K960754) granted in 1996. No sterility or single-use specifications are noted, and MRI safety data is not provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electroconvulsive Therapy - MECTA spECTrum, SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. (K965070) — FDA 510 (k ..., SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (K960754) — FDA 510 (k ..., Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M 510 (k) FDA Premarket ..., Mecta spECTrum 5000Q - MKS Medic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960754 | Class II | Active |
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Manufacturer
- Manufacturer
- Mecta Corp.
Sources (1)
- FDA 510(k) K960754 24 fields · synced Sep 20, 2026