510(k) Report

FDA applicant

Cionic

San Francisco, CA3 decisions2022–20250 recalls

FDA records 3 decisions for Cionic (San Francisco, CA) from 2022 to 2025: 3 510(k) clearances. All are in product code GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cionic, 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 Cionic’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 22025: 1
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Cionic by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cionic’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?

  • GZIStimulator, Neuromuscular, External Functional3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213622Cionic Neural Sleeve NS-100Cionic · 20221cites it
  • K221823Cionic Neural Sleeve NS-100Cionic · 20221cites it

What has FDA decided for it lately?

  • K243828Cionic Neural Sleeve (NS-200)Cionic, Inc. · 2025
  • K221823Cionic Neural Sleeve NS-100Cionic · 2022
  • K213622Cionic Neural Sleeve NS-100Cionic · 2022

All 2 as Cionic →The one decision as Cionic, Inc. →