Cleared Traditional

K002908 - JET THERAPY

K002908 is an FDA 510(k) clearance for JET THERAPY, manufactured by Jet Therapy. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K002908 · Jet Therapy · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
346d
Days
Class 1
Risk

K002908 is an FDA 510(k) clearance for the JET THERAPY. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Jet Therapy (Marana, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Jet Therapy devices

FDA 510(k) Submission Details - K002908

510(k) Number K002908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date August 30, 2001
Days to Decision 346 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
231d slower than avg
Panel avg: 115d · This submission: 346d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

All 27
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