Cleared Traditional

K233166 - NET Recovery Corp/NET Device (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K233166 · Net Recovery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
245d
Days
Class 2
Risk

K233166 is an FDA 510(k) clearance for the NET Recovery Corp/NET Device. Classified as Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR), Class II - Special Controls.

Submitted by Net Recovery (Anaheim Hills, US). The FDA issued a Cleared decision on May 29, 2024 after a review of 245 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5896 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Net Recovery devices

Submission Details

510(k) Number K233166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date May 29, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 148d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5896
Definition Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04916600 Active not recruiting Interventional

NET Device for Treating Opioid Use Disorder

NET Device as a Non-Pharmacological Alternative to Medication for Opioid Withdrawal Symptom Reduction and Abstinence

108
Patients (actual)
1
Site
Treatment
Purpose
Quadruple
Masking
Condition studied Opioid Use Disorder
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Mark K Greenwald, PhD
Sponsor Wayne State University
Started 2021-11-24 → Primary completion 2023-07-07 → Completed 2025-12-01
Primary outcome
Clinically Meaningful Decrease in Opioid Withdrawal Symptom Severity
Secondary outcome
Comparison of Change in Opioid Withdrawal Symptom Severity Between Active and Sham Device Treatment
View full study on ClinicalTrials.gov