Cleared Traditional

K093322 - MULTI-PURPOSE HEALTH DEVICE

K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co. · Neurology device
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Aug 2010
Decision
286d
Days
-
Risk

K093322 is an FDA 510(k) clearance for the MULTI-PURPOSE HEALTH DEVICE. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Upc Medical Supplies, Inc. Dba United Pacific Co. (San Gabriel, US). The FDA issued a Cleared decision on August 5, 2010 after a review of 286 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Upc Medical Supplies, Inc. Dba United Pacific Co. devices

FDA 510(k) Submission Details - K093322

510(k) Number K093322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2009
Decision Date August 05, 2010
Days to Decision 286 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 148d · This submission: 286d
Pathway characteristics
Predicate-based equivalence.

BWK Device Classification - Class 0,

Product Code BWK Stimulator, Electro-acupuncture
Device Class -