Cionic Neural Sleeve (NS-200)
FDA 510(k) K243828 · Cionic, Inc.
510(k) numberK243828
Submission
- Device name
- Cionic Neural Sleeve (NS-200)
- Applicant
- Cionic, Inc.
Scotts Valley, CA, US - Received
- December 13, 2024
- Decision date
- May 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZI
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|---|---|---|---|
| K242704 | Synchrony (20-3000)GZI · Traditional | Synapse Biomedical, Inc. | 06/05/2025SE |
| K240632 | Neuvotion NeuStim NN-01GZI · Traditional | Neuvotion, Inc. | 11/22/2024SE |
| K233006 | MyndMove, MyndMove 2.0GZI · Traditional | Myndtec, Inc. | 06/25/2024SE |
| K230997 | EvoWalk 1.0 SystemGZI · Traditional | Evolution Devices, Inc. | 12/28/2023SE |
| K221823 | Cionic Neural Sleeve NS-100GZI · Special | Cionic | 07/21/2022SE |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +)GZI · Traditional | Myolyn, LLC | 04/25/2022SE |
| K212149 | MyndMove 2.0GZI · Traditional | Myndtec, Inc. | 03/03/2022SE |
| K213622 | Cionic Neural Sleeve NS-100GZI · Traditional | Cionic | 02/14/2022SE |
| K202110 | MStim Drop Model: LGT-233GZI · Traditional | Guangzhou Longest Science & Technology Co., Ltd. | 11/05/2021SE |
| K193276 | Nerve and Muscle StimulatorGZI · Traditional | Shenzhen Xft Medical Limited | 09/23/2020SE |
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Questions and answers
When was Cionic Neural Sleeve (NS-200) cleared by the FDA?
Cionic Neural Sleeve (NS-200) (K243828) received a 510(k) decision of Substantially Equivalent on May 2, 2025, 140 days after the submission was received.
What is the product code of K243828?
The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.