Cleared Traditional

K213188 - Primary Relief

K213188 is an FDA 510(k) clearance for Primary Relief, manufactured by Dyansys, Inc.. The device is a Class 2 Neurology device with product code NHI cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K213188 · Dyansys, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
124d
Days
Class 2
Risk

K213188 is an FDA 510(k) clearance for the Primary Relief. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 31, 2022 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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

FDA 510(k) Submission Details - K213188

510(k) Number K213188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date January 31, 2022
Days to Decision 124 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
24d faster than avg
Panel avg: 148d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHI Device Classification - Class 2, Special Controls

Product Code NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,
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 - NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

All 7
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K213188.
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · Spr Therapeutics, Inc. · Jan 2023
Primary Relief
K221425 · Dyansys, Inc. · Sep 2022
ANSiStim-PP
K220397 · Dyansys, Inc. · May 2022
First Relief
K212859 · Dyansys, Inc. · Dec 2021
SPRINT PNS System
K211801 · Spr Therapeutics, Inc. · Oct 2021
SPRINT PNS System
K202660 · Spr Therapeutics, Inc. · Jan 2021