Cionic Neural Sleeve NS-100— 510(k) K221823

Substantially Equivalent

Cionic

FDA 510(k) clearance K221823 for Cionic Neural Sleeve NS-100, Substantially Equivalent on 2022-07-21. Applicant: Cionic. Device class: 2.

Clearance details

Applicant: Cionic
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2022-06-23
Decision date: 2022-07-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZI

K242704 — Synchrony (20-3000)2025-06-05
K243828 — CIONIC NEURAL SLEEVE (NS-200)2025-05-02
K240632 — Neuvotion NeuStim NN-012024-11-22
K233006 — MyndMove, MyndMove 2.02024-06-25
K230997 — EvoWalk 1.0 System2023-12-28

More clearances from Cionic

K213622 — Cionic Neural Sleeve NS-1002022-02-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.