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K800 Amplifier

BIOMETRICS LIMITED · Model K800 · UDI-DI 05060481692199

510(k) clearances

Adverse events

Recalls

Facilities

Description

A modern microprocessor controlled general purpose amplifier system which is designed to be worn by the subject. The Amplifier (K800) provides a user friendly method for collecting signals from a variety of sensors including goniometers, sEMG and related signals, in a format which may readily be connected to proprietary display and recording systems including A/D cards. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13

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.

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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.