Cleared Traditional

K050123 - P-STIM SYSTEM

K050123 · Neuroscience Therapy Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
435d
Days
-
Risk

K050123 is an FDA 510(k) clearance for the P-STIM SYSTEM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Neuroscience Therapy Corp. (Kirkland, US). The FDA issued a Cleared decision on March 30, 2006 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K050123

510(k) Number K050123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2005
Decision Date March 30, 2006
Days to Decision 435 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
286d slower than avg
Panel avg: 149d · This submission: 435d
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 K050123.
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · Inno-Health Technology, Inc. · Apr 2010
E-PULSE
K091875 · Medevice Corporation · Dec 2009
MODEL ES-130
K081943 · Ito Co., Ltd. · Nov 2008
ACULIFE, MODEL SMW-01
K051197 · Inno-Health Technology, Inc. · Mar 2006
ACUSTIM
K014273 · S.H.P. Intl. Pty., Ltd. · Jun 2002
SELECTRODE SYSTEM
K832634 · Bio-Stimu Trend Corp. · Jan 1984
K050123 · P-STIM SYSTEM
Download PDF FDA Summary Neuroscience Therapy …