Neurology · 510(k) · 2018
Sense System with IBT Electrodes
Infinite Biomedical Technologies, LLC. Cleared by FDA on 5 October 2018 under submission K182112, product code GXY (electrode, cutaneous). What FDA's record says, in FDA's words.
Device record · K182112
- Device. Sense System with IBT ElectrodesDEVICE
- Company. Infinite Biomedical Technologies, LLCCOMPANY
- Decision. 5 October 2018, 510(k), substantially equivalent (traditional review); received 6 August 2018DECISION
- Panel. NeurologyPANEL
- Product code. GXY, Electrode, CutaneousCODE
- Regulation. 21 CFR 882.1320, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, technology, and performance is provided herein to support this determination. For instances where technological differences are identified in the previous section , additional discussion describes how these differences do not raise new or different questions of safety and effectiveness. When appropriate, performance data is cited to provide evidence that the subject device is as safe and as effective as the legally marketed predicate device. The Sense System with IBT Electrodes also uses the Element System with IBT Electrodes (K173571) as the reference device. This is because the Bluetooth module and communication protocol, the UI framework, the electrodes used as well as the recommended power supply are identical to those in the Element System with the IBT Electrode which was previously cleared under K173571. Indications for Use Both the subject device and the predicate device are intended to be used exclusively for external prosthetic fittings of upper limbs . Both products are prescription use devices, intended to be installed by a prosthetist or trained clinician. Table 2. Indications for Use Characteristic Subject Device Sense System
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 534 reports filed against devices carrying product code GXY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
4 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00374
3 September 2026 · Injury · Biomet SpinalPak / OrthoPak · EBI, LLC. · report 0002242816-2026-00098
It was reported that the patient experienced skin irritation with the 63B electrodes. The patient discussed the issue with their doctor and advised that their doctor is in the process of prescribing a different device. No further information was provided.
2 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00368
2 September 2026 · Malfunction · BIS · COVIDIEN · report 2936999-2026-00370
25 August 2026 · Injury · Biomet SpinalPak / OrthoPak · EBI, LLC. · report 0002242816-2026-00096
It was reported that the electrodes irritated the patient¿s skin. The patient stated that their doctor would like them to use a different unit. No further information was provided.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GXY, in Neurology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.