Spectrum 5000 Q, 5000Q M, 4000 Q, 4000 M

The Spectrum 5000 Q, 5000Q M, 4000 Q, and 4000 M are Electroconvulsive Therapy Devices (product code QGH) designed to induce therapeutic seizures for the treatment of catatonia, major depressive disorder, and bipolar disorder. These devices deliver constant-current, bidirectional square waveform electrical stimuli through electrodes placed on the patient’s scalp or forehead. The 5000 Q and 4000 Q models provide adjustable parameters for energy and charge delivery, while the 5000 M and 4000 M feature a single stimulus intensity knob for simplified operation.

Used in hospital settings such as suites, operating rooms, or wards, these devices are intended for clinical administration by trained personnel. The Spectrum series is classified as a Class II medical device under FDA regulation 882.5940 and holds a FDA 510(k) clearance (K965070) for substantial equivalence. No specific sterility or single-use/reusable designation is provided, though typical ECT devices are reusable with appropriate maintenance. No MRI safety information is stated in the available data.