510(k) DEN170018
DEN170018 is an FDA 510(k) premarket notification submitted by Innovative Health Solutions (Ihs), Inc. for the device "NSS-2 System". The FDA issued a decision of De Novo Granted on November 15, 2017. The device falls under product code PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal), a Class II device regulated under 21 CFR 882.5896. Innovative Health Solutions (Ihs), Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 15, 2017
- Date Received
- March 17, 2017
- Clearance Type
- Direct
- 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.