Electroconvulsive Therapy (ECT) Devices

Closed Solicitation Posted

Solicitation number
36C26125Q0681
Agency
Veterans Integrated Service Network 21 Veterans Health Administration, Department of Veterans Affairs
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
PSC
6515 Medical And Surgical Instruments, Equipment, And Supplies
Place of performance
San Francisco, California 94121, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21 is seeking to procure Electroconvulsive Therapy (ECT) Devices through a sole source acquisition under FAR 13.106-1(b)(1). The agency intends to contract with SigmaStim Domestic LLC for two ECT devices and complete starter kits, justifying the sole source approach by stating that SigmaStim is the only manufacturer capable of meeting their specific requirements. The required devices must offer unique one and four knob modes, monitor seven specific physiological parameters, and activate impedance testing of all monitoring leads - capabilities that alternative FDA-approved devices cannot provide. The procurement falls under NAICS code 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) with a small business size standard of 1,250 employees. Interested parties who believe they can meet the requirements may submit responses to Leah Smith at leah.smith@va.gov by July 9, 2025, at 11:00 AM Pacific Time, though the government will only consider these responses to determine whether to conduct a competitive procurement instead of the planned sole source contract.

This procurement does not utilize any set-aside designations and specifically targets SigmaStim Domestic LLC, located at 19799 SW 95TH AVE, SUITE B, TUALATIN, OR 97062, as the intended contractor. The solicitation does not specify the exact contract value but indicates it will be structured as a firm fixed-price contract with an estimated completion date of September 30, 2025. The total quantity includes two units each of ECT devices and complete starter kits, representing a relatively small-scale acquisition. Performance will take place in San Francisco, CA 94121, specifically at the San Francisco VA Medical Center. The government emphasizes that any alternative sources must be Original Equipment Manufacturers or provide authorized distributor letters, and that responses submitted will only be evaluated to determine the viability of competitive procurement rather than for direct award consideration.

Notice text

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(1), only one source being available to meet the Government’s need.  The contract is estimated for final completion by 09/30/2025.

The North American Industrial Classification System (NAICS) code for this procurement is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing with a small business size standard of 1,250 Employees.  The FSC/PSC is 6515 – Medical and Surgical Instruments, Equipment, and Supplies.

The Department of Veterans Affairs intends to solicit a firm fixed price contract for Electroconvulsive Therapy (ECT) Devices to SigmaStim Domestic LLC, 19799 SW 95TH AVE, SUITE B, TUALATIN, OR 97062 USA. There are no other sources that will satisfy agency requirements for the necessary items.

The SigmaStim ECT Device is one of only two devices FDA approved for the necessary class of research or patient treatment. Alternative device does not offer necessary one and four knob modes/options, cannot monitor all seven of the same physiological parameters, and does not activate impedance testing of all monitoring leads. SigmaStim is the sole manufacturer and distributor of the necessary devices.

Any responsible source that feels it is capable in performing this requirement may submit a quote for the above listed items and describe and/or submit documentation to support your capabilities.  The response will be considered by the agency.  If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM.  Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Wednesday, July 9th, at 11:00 AM Pacific Time to be considered. The Government will not pay for information submitted. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.

Attachments

Files attached to this notice, newest first
File Type Posted
SOLICITATION 36C26125Q0681.pdf PDF

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