Cleared Abbreviated

COMBI 8 MAX (K070888) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K070888 · Cec Electronica S.R.L. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
461d
Days
Class 2
Risk

K070888 is an FDA 510(k) clearance for the COMBI 8 MAX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Cec Electronica S.R.L. (Mizpe Aviv, IL). The FDA issued a Cleared decision on July 3, 2008 after a review of 461 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Cec Electronica S.R.L. devices

Submission Details

510(k) Number K070888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date July 03, 2008
Days to Decision 461 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
346d slower than avg
Panel avg: 115d · This submission: 461d
Pathway characteristics
Standards-based clearance path.

Device Classification

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

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