Cleared Traditional

K992099 - BIO SPA INTELLIGENT

K992099 is an FDA 510(k) clearance for BIO SPA INTELLIGENT, manufactured by Starbene. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 942-day FDA review.

K992099 · Starbene · Physical Medicine device
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Jan 2002
Decision
942d
Days
Class 2
Risk

K992099 is an FDA 510(k) clearance for the BIO SPA INTELLIGENT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Starbene (Cordoba, Pvcia. Cordoba, AR). The FDA issued a Cleared decision on January 18, 2002 after a review of 942 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Starbene devices

FDA 510(k) Submission Details - K992099

510(k) Number K992099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1999
Decision Date January 18, 2002
Days to Decision 942 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
827d slower than avg
Panel avg: 115d · This submission: 942d
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 235
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K992099.
300 PV COMPLETE ELECTROTHERAPY SYSTEM
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MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001
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K002339 · Apex Medical Corp. · Aug 2001
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K002336 · Apex Medical Corp. · Jul 2001