Cleared Traditional

K013061 - BIOTOUCH MASSAGE THERAPY SYSTEM

K013061 is an FDA 510(k) clearance for BIOTOUCH MASSAGE THERAPY SYSTEM, manufactured by Tactile Systems Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K013061 · Tactile Systems Technology, Inc. · Physical Medicine device
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Jul 2002
Decision
293d
Days
Class 2
Risk

K013061 is an FDA 510(k) clearance for the BIOTOUCH MASSAGE THERAPY SYSTEM. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Tactile Systems Technology, Inc. (Shakopee, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 293 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Tactile Systems Technology, Inc. devices

FDA 510(k) Submission Details - K013061

510(k) Number K013061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2001
Decision Date July 01, 2002
Days to Decision 293 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 115d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 101
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K013061.
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