Cleared Traditional

K953796 - BANKS HYDRO-THERAPY CHAIR

K953796 is an FDA 510(k) clearance for BANKS HYDRO-THERAPY CHAIR, manufactured by Keith Products, Inc.. The device is a Class 2 Physical Medicine device with product code ILM cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K953796 · Keith Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
231d
Days
Class 2
Risk

K953796 is an FDA 510(k) clearance for the BANKS HYDRO-THERAPY CHAIR. Classified as Bath, Sitz, Powered (product code ILM), Class II - Special Controls.

Submitted by Keith Products, Inc. (Shelby, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 231 days - an extended review 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: 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 Keith Products, Inc. devices

FDA 510(k) Submission Details - K953796

510(k) Number K953796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date April 01, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILM Device Classification - Class 2, Special Controls

Product Code ILM Bath, Sitz, Powered
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.