510(k) Report

FDA applicant

Ampcare, LLC

Richardson, TX2 decisions2012–20130 recalls

FDA records 2 decisions for Ampcare, LLC (Richardson, TX) from 2012 to 2013: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GXY (Electrode, Cutaneous). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Ampcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Ampcare, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IPFStimulator, Muscle, Powered1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 20121cites it

What has FDA decided for it lately?

  • K131222Ampcare Esp Therapy SystemAmpcare, LLC · 2013
  • K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012

All 2 as Ampcare, LLC →