Cleared Traditional

K053509 - ACUBAND ACUPRESSURE WRIST BAND DEVICE

K053509 · Acuband, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
243d
Days
-
Risk

K053509 is an FDA 510(k) clearance for the ACUBAND ACUPRESSURE WRIST BAND DEVICE. Classified as Device, Acupressure (product code MVV).

Submitted by Acuband, Inc. (Little Silver, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 243 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.

FDA 510(k) Submission Details - K053509

510(k) Number K053509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date August 16, 2006
Days to Decision 243 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 149d · This submission: 243d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Peers - MVV Device, Acupressure

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K053509 · ACUBAND ACUPRESSURE WRIST BAND DEVICE
Download PDF FDA Summary Acuband, Inc.