← FDA Medical Device Classifications
Percutaneous Nerve Stimulator For Opioid Withdrawal
PZR · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5896
Classification
- FDA Product Code
PZR- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.5896
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Market data
- Cleared 510(k) submissions
- 8
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown