Cleared Special

ZEOBI (K121338) - FDA 510(k) Clearance

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

K121338 · Ivivi Health Science, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
85d
Days
Class 2
Risk

K121338 is an FDA 510(k) clearance for the ZEOBI. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Ivivi Health Science, LLC (San Francisco, US). The FDA issued a Cleared decision on July 27, 2012 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ivivi Health Science, LLC devices

Submission Details

510(k) Number K121338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2012
Decision Date July 27, 2012
Days to Decision 85 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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.