COMPLETE CONTROL System Gen2

K191083

Coapt, LLC · cleared 2019-05-24 · product code GXY · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. Both devices contain electronics that use various algorithms to drive a prosthetic limb.”
Algorithmpattern recognition technology
source quote (p.4)
“The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses.”
Adaptive (vs locked)No
source quote (p.9)
“The use of the same algorithm in the Gen1 and Gen2 versions of the COMPELTE CONTROL System does not raise any concerns of safety or effectiveness.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: Electrical safety testing; Electromagnetic Compatibility (EMC) testing; Cabling Connection Test; Power On and Boot Test; Bluetooth Connectivity and Profile Test; Inputs Test; Outputs Test; Calibration and Pattern Recognition Test; File Save Test

standards: IEC 60601-1, IEC 60601-1-2

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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Coapt LLC) — same firm and product code, not necessarily this device · initiated 2023-10-02

    Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

    recall event 93137 (openFDA)

  • Recalling firm matches this device's applicant (Coapt LLC) — same firm and product code, not necessarily this device · initiated 2023-10-02

    Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

    recall event 93138 (openFDA)

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/K191083