Cleared Traditional

K072534 - BIO-MAT 2000

K072534 is an FDA 510(k) clearance for BIO-MAT 2000, manufactured by Richway Intl., Inc.. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K072534 · Richway Intl., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
154d
Days
Class 2
Risk

K072534 is an FDA 510(k) clearance for the BIO-MAT 2000. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Richway Intl., Inc. (Honolulu, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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 Richway Intl., Inc. devices

FDA 510(k) Submission Details - K072534

510(k) Number K072534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2007
Decision Date February 08, 2008
Days to Decision 154 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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.