Cleared Traditional

K812033 - THE LYMAN BATHCHAIR

K812033 is an FDA 510(k) clearance for THE LYMAN BATHCHAIR, manufactured by The Lyman Bathchair Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K812033 · The Lyman Bathchair Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
24d
Days
Class 2
Risk

K812033 is an FDA 510(k) clearance for the THE LYMAN BATHCHAIR. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by The Lyman Bathchair Corp. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 24 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 - K812033

510(k) Number K812033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1981
Decision Date August 13, 1981
Days to Decision 24 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
92d faster than avg
Panel avg: 116d · This submission: 24d
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 68
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K812033.
OVERHEAD WHIRLPOOL HAND SPA BRAND
K840282 · Priest Enterprises, Inc. · Feb 1984
BIOTHERM
K833839 · Trileen, Inc. · Dec 1983
THERMOFONTE AIR MESSAGE BATH
K821809 · Greenfields · Jul 1982
CENTURY HYDROTHERAPY PUMP
K811903 · Century Manufacturing Co. · Jul 1981
CENTURY HYDRO-SAN THERAPY TANK
K811904 · Century Manufacturing Co. · Jul 1981
FOOT BATHS & HAND MASSAGERS
K810034 · Associated Mills, Inc. · Jan 1981
K812033 · THE LYMAN BATHCHAIR
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