Cleared Traditional

K833370 - LINEAR VIBRATION A MCSHIRLEY PRODUCT (FDA 510(k) Clearance)

Class I Physical Medicine device.

K833370 · Mcshirley Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
61d
Days
Class 1
Risk

K833370 is an FDA 510(k) clearance for the LINEAR VIBRATION A MCSHIRLEY PRODUCT. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Mcshirley Products, Inc. (Walker, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - the FDA physical medicine 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 Mcshirley Products, Inc. devices

Submission Details

510(k) Number K833370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1983
Decision Date November 28, 1983
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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.