510(k) Report

FDA applicant

Teleemg, LLC USA

Salem, NH2 decisions2011–20150 recalls

FDA records 2 decisions for Teleemg, LLC USA (Salem, NH) from 2011 to 2015: 2 510(k) clearances. Most are in product codes EWO (Audiometer) and IKN (Electromyograph, Diagnostic). Its devices cite 8 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2015

2011: 12015: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Teleemg, LLC USA by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teleemg, LLC USA’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EWOAudiometer1decision
  • IKNElectromyograph, Diagnostic1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K102610Focus Emg DeviceTeleemg, LLC USA · 20113cite it

What has FDA decided for it lately?

  • K141524Neuro-AudioTeleemg, LLC USA · 2015
  • K102610Focus Emg DeviceTeleemg, LLC USA · 2011

All 2 as Teleemg, LLC USA →

Other applicant names beginning “Teleemg”

FDA records each applicant name separately; these may or may not be the same firm.

Teleemg, LLC 5