Cleared Traditional

K831538 - DELUXE ADJUST-ANGLE BOARD-BK4066

K831538 is an FDA 510(k) clearance for DELUXE ADJUST-ANGLE BOARD-BK4066, manufactured by Fred Sammons, Inc.. The device is a Class 1 Physical Medicine device with product code ION cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K831538 · Fred Sammons, Inc. · Physical Medicine device
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Jun 1983
Decision
27d
Days
Class 1
Risk

K831538 is an FDA 510(k) clearance for the DELUXE ADJUST-ANGLE BOARD-BK4066. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 27 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 Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K831538

510(k) Number K831538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date June 08, 1983
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

ION Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K831538.
KNEE WALKER
K833870 · Maddak, Inc. · Nov 1983
PEDAL EXERCISER
K832968 · Maddak, Inc. · Sep 1983
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
K831543 · Fred Sammons, Inc. · Jun 1983
MADDATRAINER HAND EXERCISER
K830400 · Maddak, Inc. · Mar 1983
INFLATABLE HEAVY PLASTIC EXERCISER
K823623 · Fred Sammons, Inc. · Dec 1982
PROGRESSIVE RESISTANCE EXERCISE CUFF
K823618 · Fred Sammons, Inc. · Dec 1982