Cleared Traditional

K091875 - E-PULSE

K091875 · Medevice Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K091875

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 149d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -

Regulatory Peers - BWK Stimulator, Electro-acupuncture

All 19
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K091875.
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · Apr 2013
MULTI-PURPOSE HEALTH DEVICE
K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co. · Aug 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · Inno-Health Technology, Inc. · Apr 2010
MODEL ES-130
K081943 · Ito Co., Ltd. · Nov 2008
P-STIM SYSTEM
K050123 · Neuroscience Therapy Corp. · Mar 2006
ACULIFE, MODEL SMW-01
K051197 · Inno-Health Technology, Inc. · Mar 2006
K091875 · E-PULSE
Download PDF FDA Summary Medevice Corporation