Cleared Traditional

K801593 - LEBODY BY WATER PIK

K801593 is the FDA 510(k) clearance for LEBODY BY WATER PIK by Teledyne, Inc.. It is a Class 1 Physical Medicine device (product code ISA) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K801593 · Teledyne, Inc. · Physical Medicine device
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Aug 1980
Decision
37d
Days
Class 1
Risk

K801593 is an FDA 510(k) clearance for the LEBODY BY WATER PIK. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Teledyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Teledyne, Inc. devices

Submission Details

510(k) Number K801593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1980
Decision Date August 20, 1980
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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.