Cleared Traditional

K982544 - RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982544 · Rich-Mar Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
121d
Days
Class 2
Risk

K982544 is an FDA 510(k) clearance for the RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on November 19, 1998 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 Rich-Mar Corp. devices

Submission Details

510(k) Number K982544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date November 19, 1998
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 88
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K982544.
Ultrasound Stimulator
K240788 · Jkh Health Co., Ltd. · Jun 2025
Sonopuls 190
K230472 · Enraf-Nonius, B.V. · Oct 2023
ManaSport+
K222098 · Manamed, Inc. · Mar 2023
ManaSport
K210284 · Manamed, Inc. · Apr 2022
UltraTENS
K142976 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2015