Cleared Traditional

K990787 - TRIO 300

K990787 is an FDA 510(k) clearance for TRIO 300, manufactured by Ito Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K990787 · Ito Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
224d
Days
Class 2
Risk

K990787 is an FDA 510(k) clearance for the TRIO 300. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ito Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on October 20, 1999 after a review of 224 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Ito Co., Ltd. devices

FDA 510(k) Submission Details - K990787

510(k) Number K990787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date October 20, 1999
Days to Decision 224 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 116d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 320
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K990787.
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