Cleared Traditional

K030254 - INTERFERENTIAL STIMULATOR, MODEL RTM1000

K030254 is an FDA 510(k) clearance for INTERFERENTIAL STIMULATOR, manufactured by Ryan Telemedicine. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K030254 · Ryan Telemedicine · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
33d
Days
Class 2
Risk

K030254 is an FDA 510(k) clearance for the INTERFERENTIAL STIMULATOR, MODEL RTM1000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ryan Telemedicine (Costa Mesa, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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.

FDA 510(k) Submission Details - K030254

510(k) Number K030254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date February 26, 2003
Days to Decision 33 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
83d faster than avg
Panel avg: 116d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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

Underwriters Laboratories, Inc.
JOHN SO

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 - IPF Stimulator, Muscle, Powered

All 538
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K030254.
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
K023001 · Home Care Technology Co., Ltd. · Apr 2003
VECTORSURGE 5 MODEL 470
K030648 · Metron Medical Australia, Pty, Ltd. · Mar 2003
TENSCARE ULTIMA NMS/EMS
K023997 · Tenscare, Ltd. · Mar 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588 · Biomedical Life Systems, Inc. · Feb 2003
MEDS-4 NEUROMUSCULAR STIMULATOR
K023439 · Medical Equipment Device Specialists · Jan 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · Medical Equipment Device Specialists · Jan 2003

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.

K030254 · INTERFERENTIAL STIMULATOR, MODEL RTM1000
Download PDF FDA Summary Ryan Telemedicine