Cleared Traditional

K070672 - MASSAGE MATTRESS VM9100RM

K070672 is an FDA 510(k) clearance for MASSAGE MATTRESS VM9100RM, manufactured by Metek GmbH. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K070672 · Metek GmbH · Physical Medicine device
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Jun 2007
Decision
106d
Days
Class 2
Risk

K070672 is an FDA 510(k) clearance for the MASSAGE MATTRESS VM9100RM. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Metek GmbH (Leinefelde, DE). The FDA issued a Cleared decision on June 26, 2007 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - 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. Standard predicate reliance. 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 Metek GmbH devices

FDA 510(k) Submission Details - K070672

510(k) Number K070672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date June 26, 2007
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
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 - JFB Table, Physical Therapy, Multi Function

All 24
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K070672.
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EXTENTRAC
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