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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 116d · 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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K070672.
THERMAL MASSAGE BED, MODEL 2D-GX
K102281 · Inarex Corporation · Dec 2010
VIBRO-TRAC
K092731 · Pneumex, Inc. · Jun 2010
INAREX, MODEL 2D-LX
K080554 · Inarex Corporation · Aug 2008
AIR-FLEX WITH AUTO-DISTRACTION
K063034 · Hill Laboratories Co. · Dec 2006
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
K062476 · Ceragem International, Inc. · Oct 2006
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
K040031 · Ceragem Co., Ltd. · Jul 2004

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K070672 · MASSAGE MATTRESS VM9100RM
Download PDF FDA Summary Metek GmbH