Cleared Traditional

K844217 - RICH-MAR DELTA 330 HV

K844217 is the FDA 510(k) clearance for RICH-MAR DELTA 330 HV by Rich-Mar Corp.. It is a Class 2 Physical Medicine device (product code IMG) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K844217 · Rich-Mar Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
27d
Days
Class 2
Risk

K844217 is an FDA 510(k) clearance for the RICH-MAR DELTA 330 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. (Inola, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 27 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 K844217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1984
Decision Date November 27, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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.

Regulatory Peers - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 30
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K844217.
CURAPULS 403 DIATHERMY UNIT
K900189 · Henley Intl. · Sep 1990
ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
K895690 · Excel Tech. , Ltd. · Feb 1990
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · Henley Intl. · Sep 1987
INTELECT MODEL 700
K813594 · Chattanooga Group, Inc. · Feb 1982
RICH-MAR HV II SELECT-A-PULSE
K810526 · Rich-Mar Corp. · Apr 1981
MUSCLE STIMULATOR
K772287 · Rich-Mar Corp. · Jan 1978