Myo Plus

K191179

Otto Bock Healthcare Products GmbH · cleared 2019-09-04 · product code GXY · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“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.”
Algorithmmeasures electromyographic control signals and assigns them to movements via a learning control unit using pattern recognition
source quote (p.5)
“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.”
Adaptive (vs locked)Yes
source quote (p.5)
“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.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Functional testing; Adaptation to the user through calibration; Commissioning by user; Pattern recognition; Wireless data transmission; Product compatibility; Product lifetime; Battery life

standards: IEC 60601-1:2005/A1:2012, IEC 60601-1-11:2015, IEC 60601-1-2:2012, ISO 10993-1:2009, IEC 62133-2:2017, ST/SG/AC.10/11/Rev.5/Amend.2, Sub-section 38.3

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
57
MAUDE reports in code, 12mo
+38%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K191179