Cleared Traditional

K991693 - TWO RIVERS POWER LIFT/RECLINE CHAIR

K991693 is an FDA 510(k) clearance for TWO RIVERS POWER LIFT/RECLINE CHAIR, manufactured by Two Rivers, LLC. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K991693 · Two Rivers, LLC · Physical Medicine device
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Aug 1999
Decision
91d
Days
Class 2
Risk

K991693 is an FDA 510(k) clearance for the TWO RIVERS POWER LIFT/RECLINE CHAIR. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Two Rivers, LLC (New Tazewell, US). The FDA issued a Cleared decision on August 17, 1999 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - 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 Two Rivers, LLC devices

FDA 510(k) Submission Details - K991693

510(k) Number K991693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date August 17, 1999
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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 - INO Chair, Positioning, Electric

All 16
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K991693.
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · Merits Health Products Co., Ltd. · Mar 2006
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · Medline Industries, Inc. · Sep 2000
INVACARE LIFT CHAIR
K002171 · Invacare Corp. · Aug 2000
PREVENT I
K973373 · The Buzzz Corp. · Feb 1998
ELECTRIC SEAT LIFT CHAIR
K961663 · Ken Kemmerer · May 1996
TMR48
K953342 · Pride Health Care, Inc. · Sep 1995