Cleared Special

K091933 - ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01

K091933 · Inno-Health Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
276d
Days
-
Risk

K091933 is an FDA 510(k) clearance for the ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Inno-Health Technology, Inc. (Taichung, TW). The FDA issued a Cleared decision on April 2, 2010 after a review of 276 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inno-Health Technology, Inc. devices

FDA 510(k) Submission Details - K091933

510(k) Number K091933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date April 02, 2010
Days to Decision 276 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
128d slower than avg
Panel avg: 148d · This submission: 276d
Pathway characteristics
Modification to existing cleared device.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -