Cleared Abbreviated

K070888 - COMBI 8 MAX

K070888 is an FDA 510(k) clearance for COMBI 8 MAX, manufactured by Cec Electronica S.R.L.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 461-day FDA review.

K070888 · Cec Electronica S.R.L. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K070888

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 116d · This submission: 461d
Pathway characteristics
Standards-based clearance path.

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 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K070888.
COMPEX REHAB
K090632 · Chattanooga Group · Jun 2009
STIWELL MED4
K080950 · Otto Bock, Austria GmbH · Apr 2009
SRT II MUSCLE STIMULATOR
K071677 · Therapeutic Innovations, Inc. · Jul 2008
BIOMOVE 5000 SYSTEM
K080787 · Curatronic, Ltd. · Apr 2008
MODELS TENS 7000, EMS 7500 AND TWIN STIM
K080661 · Koalaty Products, Inc. · Mar 2008
MUSCLE PAIN DEVICE (MPD)
K073361 · Stevens Proof of Concept, Inc. · Mar 2008
K070888 · COMBI 8 MAX
Download PDF FDA Summary Cec Electronica S.R.L.