Salient Characteristics.docx
DOCX document 33 KB Posted
- Solicitation number
- 36C26126Q0783
About this file
This is a Brand Name or Equal Worksheet documenting the salient characteristics for a Biodex Balance System SD, Model BI-950-440, a computerized balance assessment and training system intended for procurement by the VA Northern California Health Care System (VANCHCS). The device is designed to provide objective, reliable, and clinically validated assessment and training of balance, postural stability, and fall risk for patients through standardized testing protocols, dynamic and static stability measurements, and interactive neuromuscular training with real-time biofeedback. The equipment has maximum dimensions of 30 inches width by 44 inches depth by 74 inches height and is manufactured by Biodex Medical Systems, Inc.
The equipment meets all required regulatory standards including FDA approval, IEC 606011 compliance, ANSI/AAMI ES606011, Canadian electrical safety standards (CAN/CSA C22.2 No. 606011), ETL listing to UL 606011, FCC and IC compliance for RF emissions, and CE Mark designation for European Union standards. The procurement is associated with a Sources Sought announcement (Solicitation Number 36C26126Q0783) to survey market capabilities among qualified sources within NAICS code 339112 (Surgical and Medical Instrument Manufacturing). The manufacturer provides a one-year parts and labor warranty with ongoing support and offers training through their Biodex University e-learning platform. The worksheet certifies that the listed salient characteristics are essential to Government requirements and that the specified restrictions will not limit acquisition to items peculiar to one manufacturer.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| 36C26126Q0783.docx | DOCX document |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Brand Name or Equal Worksheet (“Salient Characteristics”) 6/3/2026 Brand Name Item: Biodex Balance System SD
1) Essential/significant physical, functional, or performance characteristics.
| a) | Compatibility – n/a |
| b) | Dimensions – MAXIMUM 30″ W × 44″ D × 74″ H (76 cm × 112 cm × 188 cm) |
| c) | Industry Standard –n/a |
| d) | Purpose - The purpose of the Biodex Balance System SD is to provide objective, reliable, and clinically validated assessment and training of balance, postural stability, and fall risk for patients. The device delivers standardized testing protocols, dynamic and static stability measurements, and interactive neuromuscular training with real‑time biofeedback, enabling accurate evaluation, targeted rehabilitation, and improved documentation of patient outcomes. |
| e) | Governing Body or Organization – |
The Food and Drug Administration (FDA) regulates medical devices sold in the United States to assure their safety and effectiveness. Items purchased for use at the Department of Veterans Affairs must be FDA approved.
IEC 60601‑1 (Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance) compliance confirmed under IEC 60601‑1:2012 IEC 60601‑1‑2 (Electromagnetic Compatibility – EMC standards), with detailed emission and immunity specifications ANSI/AAMI ES60601‑1 (U.S. adaptation of IEC 60601‑1) CAN/CSA C22.2 No. 60601‑1 (Canadian electrical safety standard) ETL listing to UL 60601‑1 (electrical safety for medical equipment) CE Mark, indicating conformity with relevant European Union health, safety, and environmental protection standards FCC and IC compliance for RF emissions in the U.S. and Canada
2) Complete generic identification – Computerized Balance Assessment and Training System
3) Applicable model/make/catalog number – Biodex Balance System SD, 950-440 (BI-950-440)
4) Manufacturer name – Biodex Medical Systems, Inc.
5) Warranty - One-year parts and labor with ongoing support on all equipment.
6) Installation/Training - http://www.biodexrehabautomation.com/physical-medicine/biodex-university/training-interactive-elearning.html
7) Security- User account Per VAAR 811.104 and 811.105, I certify the following regarding the above information:
1. The salient characteristics listed above are essential to the Government’s requirements.
2. To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.
File details come from the government source that posted it. Updated .