Cleared Traditional

K051397 - BIOBANDS

K051397 · Biobands Distributors, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
112d
Days
-
Risk

K051397 is an FDA 510(k) clearance for the BIOBANDS. Classified as Device, Acupressure (product code MVV).

Submitted by Biobands Distributors, Inc. (Washington, US). The FDA issued a Cleared decision on September 16, 2005 after a review of 112 days - within the typical 510(k) review window.

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 - K051397

510(k) Number K051397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date September 16, 2005
Days to Decision 112 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
37d faster than avg
Panel avg: 149d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Peers - MVV Device, Acupressure

All 12
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K051397 · BIOBANDS
Download PDF FDA Summary Biobands Distributors…