Cleared Traditional

K821133 - ELECTRICAL VIBRATING DEVICE

K821133 is an FDA 510(k) clearance for ELECTRICAL VIBRATING DEVICE, manufactured by Durham Electric Co.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K821133 · Durham Electric Co. · Physical Medicine device
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Jul 1982
Decision
80d
Days
Class 1
Risk

K821133 is an FDA 510(k) clearance for the ELECTRICAL VIBRATING DEVICE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Durham Electric Co. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1982 after a review of 80 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.

FDA 510(k) Submission Details - K821133

510(k) Number K821133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date July 09, 1982
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 116d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

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.

Regulatory Peers - IRO Vibrator, Therapeutic

All 63
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K821133.
ELECTRO-SAGE MODEL 203
K842379 · Weingart, Inc. · Aug 1984
LINEAR VIBRATION A MCSHIRLEY PRODUCT
K833370 · Mcshirley Products, Inc. · Nov 1983
NORELCO VIBRATING BOARD V900
K830715 · North American Philips Corp. · May 1983
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633 · Fred Sammons, Inc. · Jun 1982
ACUPRESS VIBRATOR
K812902 · Eicona Corp. · Nov 1981
VIBRATOR
K810446 · Fred Sammons, Inc. · Mar 1981
K821133 · ELECTRICAL VIBRATING DEVICE
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