Cleared Traditional

K220397 - ANSiStim-PP (FDA 510(k) Clearance)

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

K220397 · Dyansys, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
90d
Days
Class 2
Risk

K220397 is an FDA 510(k) clearance for the ANSiStim-PP. 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 May 12, 2022 after a review of 90 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

Submission Details

510(k) Number K220397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2022
Decision Date May 12, 2022
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03540446 Unknown Interventional Industry-sponsored

First Relief Treatment for Peripheral Neuropathy

To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy

66
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Peripheral Neuropathy
Study design Factorial
Eligibility All sexes · 18 Years+
Principal investigator Dr. Gurunath, Ph.D
Sponsor DyAnsys, Inc. (industry)
Started 2018-04-04 → Primary completion 2018-09-15 → Completed 2018-10-01
Primary outcome
Reduction of Neuropathy pain
Secondary outcome
Check for delay of Re-occurrence of pain within a short time
View full study on ClinicalTrials.gov

Regulatory Peers - NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

All 12
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K220397.
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · Spr Therapeutics, Inc. · Jan 2023
Primary Relief
K221425 · Dyansys, Inc. · Sep 2022
Primary Relief
K213188 · Dyansys, Inc. · Jan 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