510(k) K212859
K212859 is an FDA 510(k) premarket notification submitted by Dyansys, Inc. for the device "First Relief". The FDA issued a decision of Substantially Equivalent on December 20, 2021. The device falls under product code NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Dyansys, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2021
- Date Received
- September 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,