NET Recovery Corp/NET Device

FDA 510(k) K233166 · Net Recovery

Substantially Equivalent

510(k) numberK233166

Submission

Device name
NET Recovery Corp/NET Device
Applicant
Net Recovery
Anaheim Hills, CA, US
Received
September 27, 2023
Decision date
May 29, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5896
Specialty
Neurology

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

Other 510(k)s with product code PZR

510(k)DeviceApplicantDecision
K251246Sparrow AscentPZR · Traditional Spark Biomedical, Inc.08/25/2025SE
K230796Sparrow AscentPZR · Traditional Spark Biomedical, Inc.06/20/2023SE
K221231Drug Relief v1PZR · Special Dyansys, Inc.06/06/2022SE
K211971Drug Relief v1PZR · Traditional Dyansys, Inc.11/05/2021SE
K201873Sparrow Therapy SystemPZR · Traditional Spark Biomedical, Inc.01/02/2021SE
K173861Drug ReliefPZR · Traditional Dyansys, Inc.05/02/2018SE

Questions and answers

When was NET Recovery Corp/NET Device cleared by the FDA?

NET Recovery Corp/NET Device (K233166) received a 510(k) decision of Substantially Equivalent on May 29, 2024, 245 days after the submission was received.

What is the product code of K233166?

The FDA product code is PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal, a Class II (moderate risk) device regulated under 21 CFR 882.5896.