Cleared Traditional

K040905 - WELLNESS/JOLIVETE

K040905 is an FDA 510(k) clearance for WELLNESS/JOLIVETE, manufactured by Tohkai Precision Ind. , Ltd.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K040905 · Tohkai Precision Ind. , Ltd. · Physical Medicine device
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Feb 2005
Decision
322d
Days
Class 2
Risk

K040905 is an FDA 510(k) clearance for the WELLNESS/JOLIVETE. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Tohkai Precision Ind. , Ltd. (Saint Petersburg, US). The FDA issued a Cleared decision on February 23, 2005 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tohkai Precision Ind. , Ltd. devices

FDA 510(k) Submission Details - K040905

510(k) Number K040905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date February 23, 2005
Days to Decision 322 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 115d · This submission: 322d
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 121
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