Cleared Special

K102281 - THERMAL MASSAGE BED, MODEL 2D-GX

K102281 is an FDA 510(k) clearance for THERMAL MASSAGE BED, manufactured by Inarex Corporation. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Special 510(k) pathway after a 133-day FDA review.

K102281 · Inarex Corporation · Physical Medicine device
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Dec 2010
Decision
133d
Days
Class 2
Risk

K102281 is an FDA 510(k) clearance for the THERMAL MASSAGE BED, MODEL 2D-GX. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Inarex Corporation (Yuseong-Gu, Daejon, KR). The FDA issued a Cleared decision on December 22, 2010 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inarex Corporation devices

FDA 510(k) Submission Details - K102281

510(k) Number K102281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2010
Decision Date December 22, 2010
Days to Decision 133 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
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 - JFB Table, Physical Therapy, Multi Function

All 21
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K102281.
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