510(k) K211971
K211971 is an FDA 510(k) premarket notification submitted by Dyansys, Inc. for the device "Drug Relief v1". The FDA issued a decision of Substantially Equivalent on November 5, 2021. The device falls under product code PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal), a Class II device regulated under 21 CFR 882.5896. Dyansys, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2021
- Date Received
- June 24, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Nerve Stimulator For Opioid Withdrawal
- Device Class
- Class II
- Regulation Number
- 882.5896
- Review Panel
- NE
- Submission Type
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.