Cleared Traditional

K813099 - BACK RIE

K813099 is the FDA 510(k) clearance for BACK RIE by Back Rite. It is a Class 1 Physical Medicine device (product code ION) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K813099 · Back Rite · Physical Medicine device
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Nov 1981
Decision
21d
Days
Class 1
Risk

K813099 is an FDA 510(k) clearance for the BACK RIE. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Back Rite (Walker, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5370 - 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.

View all Back Rite devices

Submission Details

510(k) Number K813099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1981
Decision Date November 24, 1981
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ION Exerciser, Non-measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5370
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 - ION Exerciser, Non-measuring

All 25
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K813099.
VISCO HANDEX-VARIOUS MODELS
K821855 · Fred Sammons, Inc. · Jul 1982
BK-5305 MULTIPLE HAND GRID
K821857 · Fred Sammons, Inc. · Jul 1982
MODELING COMPOUND AND FOAM EXERCISER
K813633 · Fred Sammons, Inc. · Jan 1982
NON-MEASURING EXERCISERS
K812351 · Fred Sammons, Inc. · Sep 1981
BABY WALKER W/TOY CHEST
K812474 · Maddak, Inc. · Sep 1981
NON-MEASURING EXERCISERS
K810444 · Fred Sammons, Inc. · Mar 1981