Cleared Traditional

LOUNGE, TILT-A-BODY STRETCH (K790572) - FDA 510(k) Clearance

Class I Physical Medicine device.

K790572 · Innovative Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
18d
Days
Class 1
Risk

K790572 is an FDA 510(k) clearance for the LOUNGE, TILT-A-BODY STRETCH. Classified as Exerciser, Non-measuring (product code ION), Class I - General Controls.

Submitted by Innovative Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1979 after a review of 18 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 Innovative Products, Inc. devices

Submission Details

510(k) Number K790572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1979
Decision Date April 10, 1979
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 42
Devices cleared under the same product code (ION) and FDA review panel - the closest regulatory comparables to K790572.
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
K831543 · Fred Sammons, Inc. · Jun 1983
DELUXE ADJUST-ANGLE BOARD-BK4066
K831538 · Fred Sammons, Inc. · Jun 1983
INFLATABLE HEAVY PLASTIC EXERCISER
K823623 · Fred Sammons, Inc. · Dec 1982
PROGRESSIVE RESISTANCE EXERCISE CUFF
K823618 · Fred Sammons, Inc. · Dec 1982
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH
K823619 · Fred Sammons, Inc. · Dec 1982
PLASTIC ELASTOMER IN CUBE FORM EXERCISE
K823620 · Fred Sammons, Inc. · Dec 1982