Cleared Traditional

E-PULSE (K091875) - FDA 510(k) Clearance

K091875 · Medevice Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
167d
Days
-
Risk

K091875 is an FDA 510(k) clearance for the E-PULSE. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Medevice Corporation (Pompano Beach, US). The FDA issued a Cleared decision on December 7, 2009 after a review of 167 days - an extended review cycle.

This device falls under the Neurology FDA review panel. 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 Medevice Corporation devices

Submission Details

510(k) Number K091875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date December 07, 2009
Days to Decision 167 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 148d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 22
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K091875.
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030 · Wuxi Jiajian Medical Instrument Co., Ltd. · Mar 2025
Needle Stimulator (Model: RJNS6-1)
K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Mar 2022
Needle Stimulator
K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021