Cleared Traditional

K051197 - ACULIFE

K051197 · Inno-Health Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
322d
Days
-
Risk

K051197 is an FDA 510(k) clearance for the ACULIFE, MODEL SMW-01. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Inno-Health Technology, Inc. (Taichung, TW). The FDA issued a Cleared decision on March 28, 2006 after a review of 322 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inno-Health Technology, Inc. devices

FDA 510(k) Submission Details - K051197

510(k) Number K051197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date March 28, 2006
Days to Decision 322 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -