510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZRClass II

Percutaneous Nerve Stimulator For Opioid Withdrawal

21 CFR 882.5896 / Neurology
FDA source (opens on fda.gov)

PZR is the FDA product code for Percutaneous Nerve Stimulator For Opioid Withdrawal, a class II device type, regulated under 21 CFR 882.5896. FDA's definition for this code reads: "Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PZR
Device name
Percutaneous Nerve Stimulator For Opioid Withdrawal
FDA definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Regulation
21 CFR 882.5896
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code PZR

By decision year
8 clearances under product code PZR with a decision year between 2017 and 2025, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PZR by decision year
YearClearances
20171
20181
20212
20221
20231
20241
20251

Applicants with the most clearances

Product code PZR
Applicants holding the most 510(k) clearances under product code PZR
ApplicantClearances
Dyansys, Inc.3
Spark Biomedical Inc.3
Innovative Health Solutions (Ihs), Inc.1
Net Recovery Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code