Not Cleared Direct

DEN230015 - Osteoboost Belt (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230015 · Bone Health Technologies, Inc. · Orthopedic device
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Jan 2024
Decision
329d
Days
Class 2
Risk

DEN230015 is an FDA 510(k) submission (not cleared) for the Osteoboost Belt. Classified as Wearable Vibration Device For Orthopedic Use (product code QZO), Class II - Special Controls.

Submitted by Bone Health Technologies, Inc. (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on January 12, 2024 after a review of 329 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5895 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 329 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Bone Health Technologies, Inc. devices

Submission Details

510(k) Number DEN230015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 17, 2023
Decision Date January 12, 2024
Days to Decision 329 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics

Device Classification

Product Code QZO Wearable Vibration Device For Orthopedic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.5895
Definition A Wearable Vibration Device For Orthopedic Use Is A Wearable Device That Uses Mechanical Vibrations, Targeted To Specific Regions Of The Skeleton, To Reduce Loss Of Bone Strength Or Bone Mineral Density.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.