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DataLITE AD2 Wireless Adaptor

BIOMETRICS LIMITED · Model AD2 · UDI-DI 05060481690621

IKK
10
510(k) clearances
47
Adverse events
4
Recalls
57
Facilities

Description

The DataLITE AD2 Adaptor is used with the DataLITE DG2 Dongle to readily interface the following devices: Dynamometer, MyoMeter, Pinchmeter, ForcePlates and Load Cells.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

Recalls

DateFirmReason
2023-05-31Trexo 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.
2020-06-08Hocoma AGThe 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
2013-12-03MedX Holdings, Inc.Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
2012-05-05Interactive 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.