Cleared Traditional

K792641 - HYDRO PULSE MASSAGE

K792641 is an FDA 510(k) clearance for HYDRO PULSE MASSAGE, manufactured by Hydro-Pulse Research, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K792641 · Hydro-Pulse Research, Inc. · Physical Medicine device
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Jan 1980
Decision
33d
Days
Class 2
Risk

K792641 is an FDA 510(k) clearance for the HYDRO PULSE MASSAGE. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Hydro-Pulse Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1980 after a review of 33 days - a notably fast clearance cycle.

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: 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 - K792641

510(k) Number K792641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1979
Decision Date January 28, 1980
Days to Decision 33 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
83d faster than avg
Panel avg: 116d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ILJ Bath, Hydro-massage

All 72
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K792641.
CENTURY HYDRO-SAN THERAPY TANK
K811904 · Century Manufacturing Co. · Jul 1981
FOOT BATHS & HAND MASSAGERS
K810034 · Associated Mills, Inc. · Jan 1981
WHIRLPOOL BATHING UNIT-#2001
K802335 · Aqua Care Corp. · Oct 1980
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
K791718 · Universal-Kundle Corp. · Oct 1979
GILLETTE CORDLESS WHIRLPOOL
K791603 · The Gillette Company · Sep 1979
VIBRO BATH MODEL FS-1
K771966 · Dazey Products Co. · Nov 1977
K792641 · HYDRO PULSE MASSAGE
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