Cleared Traditional

K800958 - PERSONAL SITZ BATH KIT (FDA 510(k) Clearance)

Class I Physical Medicine device.

K800958 · The Healthcare Group Laboratories, Inc. · Physical Medicine device
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May 1980
Decision
9d
Days
Class 1
Risk

K800958 is an FDA 510(k) clearance for the PERSONAL SITZ BATH KIT. Classified as Bath, Sitz, Nonpowered (product code KTC), Class I - General Controls.

Submitted by The Healthcare Group Laboratories, Inc.. The FDA issued a Cleared decision on May 2, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5125 - 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 The Healthcare Group Laboratories, Inc. devices

Submission Details

510(k) Number K800958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date May 02, 1980
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTC Bath, Sitz, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5125
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.