Cionic Neural Sleeve NS-100— 510(k) K213622

Substantially Equivalent

Cionic

FDA 510(k) clearance K213622 for Cionic Neural Sleeve NS-100, Substantially Equivalent on 2022-02-14. 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: 2021-11-16
Decision date: 2022-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZI

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K233006 — MyndMove, MyndMove 2.02024-06-25
K230997 — EvoWalk 1.0 System2023-12-28

More clearances from Cionic

K221823 — Cionic Neural Sleeve NS-1002022-07-21

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