Alpha Control Liner System (ACLS)

K223738

Coapt · cleared 2023-01-11 · product code GXY · Neurology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.7)
“The Alpha Control Liner System contains hardware that is functionally equivalent to the predicate device. Both devices contain electronics that use various algorithms to process surface electromyography signals into a digital signal that can be used by the pattern recognition algorithm to control a prosthetic limb.”
Algorithmpattern recognition algorithm
source quote (p.7)
“Both devices contain electronics that use various algorithms to process surface electromyography signals into a digital signal that can be used by the pattern recognition algorithm to control a prosthetic limb.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: overall design and electrical safety results; design output meets the design inputs and specifications for the device

standards: IEC 60601-1, ISO 10993-5, ISO 10993-10

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/K223738