Cleared Traditional

MEDO BUBBLE BATH MA-80, 400, 600 & 700 (K844064) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844064 · Medo U.S.A., Inc. · Physical Medicine device
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Jan 1985
Decision
97d
Days
Class 2
Risk

K844064 is an FDA 510(k) clearance for the MEDO BUBBLE BATH MA-80, 400, 600 & 700. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Medo U.S.A., Inc. (Wood Dale, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Medo U.S.A., Inc. devices

Submission Details

510(k) Number K844064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date January 23, 1985
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.