Cleared Traditional

K963526 - STRAP WEDGE (FDA 510(k) Clearance)

Class I General Hospital device.

K963526 · Alimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
54d
Days
Class 1
Risk

K963526 is an FDA 510(k) clearance for the STRAP WEDGE. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Alimed, Inc. (Dedham, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital device framework. 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 Alimed, Inc. devices

Submission Details

510(k) Number K963526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1996
Decision Date October 28, 1996
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 128d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.