Cleared Traditional

K900588 - ACU-BAND ACCUPRESSURE WRIST BAND (FDA 510(k) Clearance)

K900588 · Euro-Am Pharma, Inc. · Neurology device
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Feb 1990
Decision
15d
Days
-
Risk

K900588 is an FDA 510(k) clearance for the ACU-BAND ACCUPRESSURE WRIST BAND. Classified as Device, Acupressure (product code MVV).

Submitted by Euro-Am Pharma, Inc. (Fanwood, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 15 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 Euro-Am Pharma, Inc. devices

Submission Details

510(k) Number K900588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date February 22, 1990
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -