Cleared Traditional

K841697 - HYDRO-THERO PAD

K841697 is the FDA 510(k) clearance for HYDRO-THERO PAD by Maddak, Inc.. It is a Class 2 Physical Medicine device (product code IRT) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K841697 · Maddak, Inc. · Physical Medicine device
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May 1984
Decision
16d
Days
Class 2
Risk

K841697 is an FDA 510(k) clearance for the HYDRO-THERO PAD. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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 Maddak, Inc. devices

Submission Details

510(k) Number K841697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date May 09, 1984
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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.