Cleared Traditional

K211971 - Drug Relief v1 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211971 · Dyansys, Inc. · Neurology device
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Nov 2021
Decision
134d
Days
Class 2
Risk

K211971 is an FDA 510(k) clearance for the Drug Relief v1. Classified as Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR), Class II - Special Controls.

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on November 5, 2021 after a review of 134 days - within the typical 510(k) review window.

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 Dyansys, Inc. devices

Submission Details

510(k) Number K211971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2021
Decision Date November 05, 2021
Days to Decision 134 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
14d faster than avg
Panel avg: 148d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PZR Percutaneous Nerve Stimulator For Opioid Withdrawal

All 7
Devices cleared under the same product code (PZR) and FDA review panel - the closest regulatory comparables to K211971.
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