BURT

BARRETT TECHNOLOGY, LLC · Model M1400 · UDI-DI 00867504000413

510(k) clearances

Adverse events

Recalls

Facilities

Description

BURT Rehabilitation System is indicated to aid in the rehabilitation and evaluation of upper extremities for patients suffering from neurological or musculoskeletal injuries or conditions. BURT is a robotic system with 3 actuators (DC motors) in the base, a relatively thin “arm” section composed of two links (“inner” and “outer”) connected via a rotating joint (driven by the 3rd actuator via cables), electronics to drive the system, firmware and software that control the system and provide therapeutic activities and games for the patient, and a stand that supports the system.

Recalls

Date	Firm	Reason
2023-05-31	Trexo Robotics Holdings Inc.	Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
2020-06-08	Hocoma AG	The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrol
2013-12-03	MedX Holdings, Inc.	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05	Interactive Motion Technologies, Inc.	Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.