Cleared Traditional

K854710 - BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID

K854710 is the FDA 510(k) clearance for BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID by Reloke Co.. It is a Class 1 Physical Medicine device (product code KNN) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K854710 · Reloke Co. · Physical Medicine device
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Apr 1986
Decision
146d
Days
Class 1
Risk

K854710 is an FDA 510(k) clearance for the BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Reloke Co. (Los Angeles, US). The FDA issued a Cleared decision on April 16, 1986 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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 Reloke Co. devices

Submission Details

510(k) Number K854710 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 21, 1985
Decision Date April 16, 1986
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KNN Components, Wheelchair

All 10
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K854710.
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
K821488 · Electro-Catheter Corp. · May 1982