Cleared Traditional

ACUPUNCTURE INSOLES (K840995) - FDA 510(k) Clearance

K840995 · Lu LU Enterprise Co. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
19d
Days
-
Risk

K840995 is an FDA 510(k) clearance for the ACUPUNCTURE INSOLES. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Lu LU Enterprise Co. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1984 after a review of 19 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.

View all Lu LU Enterprise Co. , Ltd. devices

Submission Details

510(k) Number K840995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1984
Decision Date March 27, 1984
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -