Cleared Traditional

K140788 - P-STIM

K140788 · Biegler GmbH · Neurology device
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Jun 2014
Decision
88d
Days
-
Risk

K140788 is an FDA 510(k) clearance for the P-STIM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Biegler GmbH (Bonita Springs, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K140788

510(k) Number K140788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date June 27, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 149d · This submission: 88d
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 18
Devices cleared under the same product code (BWK) and FDA review panel - the closest regulatory comparables to K140788.
ANSISTIM
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K130768 · Wuxi Jiajian Medical Instrument Co., Ltd. · Aug 2013
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
K140788 · P-STIM
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