Cionic Neural Sleeve NS-100
FDA 510(k) K221823 · Cionic
510(k) numberK221823
Submission
- Device name
- Cionic Neural Sleeve NS-100
- Applicant
- Cionic
San Francisco, CA, US - Received
- June 23, 2022
- Decision date
- July 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242704 | Synchrony (20-3000)GZI · Traditional | Synapse Biomedical, Inc. | 06/05/2025SE |
| K243828 | Cionic Neural Sleeve (NS-200)GZI · Traditional | Cionic, Inc. | 05/02/2025SE |
| 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 |
| 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 |
More from Shenzhen Xft Medical Limited
Questions and answers
When was Cionic Neural Sleeve NS-100 cleared by the FDA?
Cionic Neural Sleeve NS-100 (K221823) received a 510(k) decision of Substantially Equivalent on July 21, 2022, 28 days after the submission was received.
What is the product code of K221823?
The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.