Cleared Traditional

K771157 - RM VI-HV (FDA 510(k) Clearance)

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

K771157 · Rich-Mar Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1977
Decision
23d
Days
Class 2
Risk

K771157 is an FDA 510(k) clearance for the RM VI-HV. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rich-Mar Corp. devices

Submission Details

510(k) Number K771157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1977
Decision Date July 21, 1977
Days to Decision 23 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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.