Neurology · 510(k) · 2019
Myo Plus
Otto Bock Healthcare Products GmbH. Cleared by FDA on 4 September 2019 under submission K191179, product code GXY (electrode, cutaneous). What FDA's record says, in FDA's words.
Device record · K191179
- Device. Myo PlusDEVICE
- Company. Otto Bock Healthcare Products GmbH (AT)COMPANY
- Decision. 4 September 2019, 510(k), substantially equivalent (traditional review); received 2 May 2019DECISION
- Panel. NeurologyPANEL
- Product code. GXY, Electrode, CutaneousCODE
- Regulation. 21 CFR 882.1320, Class IIREG
- Source. FDA database entry · decision document (7 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.
Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs. PREMARKET NOTIFICATION MYO PLUS Project Report No. PD-PP00120325A-200 Attachment X 5 Device Description MYO PLUS measures the electromyographic control signals of the user and assigns them to the movements of the prosthesis, such as the hand or rotation unit. The product is the central control unit of a myoelectric prosthesis. By calibrating via the Myo Plus App, the control unit learns to assign muscle signals from the user to the various types of movement. This calibration can be performed by the users themselves, and repeated at regular intervals if necessary. Description of the components: Myo Plus TR The central control unit is installed in the forearm of the prosthesis and is supplied with energy by the battery system of the prosthesis. Up to 8 remote electrodes can be connected. The electronics handles the signal processing of the electrode signals and controls the compatible prosthesis components. Remote Electrode The remote electrodes take the muscle signal from the skin surface and transmit it to MyoPlus TR. The electrode contacts are located on a flexible cable and are individually screwed into the socket by the prosthesist. Myo Plus App The Myo Plus App is the central interface for the user and/or professionals to make settings on the control system or monitor operating states. The data transfer to mobile setting systems on Android or mobile iOS devices shall be carried […]
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.
- Mentionstriage or notification
- Mentionsmeasurement or quantification
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, from Otto Bock Healthcare Products GmbH, or cleared in 2019. 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.