K221199
- 510(k) number
- K221199
- Device name
- Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
- Applicant
- Green Island International Tcm Group Limited CN
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2023-12-19
- Date received
- 2022-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K221199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.