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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 116d · 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 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K102281.
CHOYANG THERMAL MASSAGER
K111941 · Choyang Medical Instrument Co., Ltd. · May 2012
ACQPOINT THERMAJADE MASSAGE TABLE
K102938 · Acqpoint, Inc. · Sep 2011
NM-7000
K111329 · Nuga Medical Co., Ltd. · Sep 2011
VIBRO-TRAC
K092731 · Pneumex, Inc. · Jun 2010
INAREX, MODEL 2D-LX
K080554 · Inarex Corporation · Aug 2008
MASSAGE MATTRESS VM9100RM
K070672 · Metek GmbH · Jun 2007
K102281 · THERMAL MASSAGE BED, MODEL 2D-GX
Download PDF FDA Summary Inarex Corporation