DeviceClearance

Product code PZR— Neurology

Drug Relief v1

Classification name
Percutaneous Nerve Stimulator For Opioid Withdrawal
Device class
Class 2
Regulation
21 CFR 882.5896
Advisory panel
Neurology
Total cleared
8
First cleared
Most recent

FDA classification definition

“Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.”

— U.S. Food and Drug Administration, device classification record for product code PZR under 21 CFR 882.5896, via openFDA

Market context for product code PZR

FDA has cleared 8 devices under product code PZR between 2017 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZR

Recent clearances under product code PZR

Data sourced from openFDA. This site is unofficial and independent of the FDA.