Cleared Special

K170391 - ANSiStim-PP (FDA 510(k) Clearance)

K170391 · Dyansys, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
29d
Days
-
Risk

K170391 is an FDA 510(k) clearance for the ANSiStim-PP. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dyansys, Inc. devices

Submission Details

510(k) Number K170391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2017
Decision Date March 09, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K170391.
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AXUS ES-5 Electro-Acupuncture Device
K200636 · Lhasa Oms, Inc. · Feb 2021