510(k) Report

FDA applicant

Ziip,Llc

Piedmont, CA2 decisions2017–20210 recalls

FDA records 2 decisions for Ziip,Llc (Piedmont, CA) from 2017 to 2021: 2 510(k) clearances. All are in product code NFO (Stimulator, Transcutaneous Electrical…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ziip, Inc.”.

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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2021

2017: 12021: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ziip,Llc by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ziip,Llc’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?

  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K212342ZIIP+ DeviceZiip, Inc. · 20212cite it
  • K161484ZIIP DeviceZiip,Llc · 20171cites it

What has FDA decided for it lately?

  • K212342ZIIP+ DeviceZiip, Inc. · 2021
  • K161484ZIIP DeviceZiip,Llc · 2017

The one decision as Ziip,Llc →The one decision as Ziip, Inc. →