Cleared Traditional

K021763 - RS2MI MUSCLE STIMULATOR FAMILY

K021763 is an FDA 510(k) clearance for RS2MI MUSCLE STIMULATOR FAMILY, manufactured by Rs Medical. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K021763 · Rs Medical · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
15d
Days
Class 2
Risk

K021763 is an FDA 510(k) clearance for the RS2MI MUSCLE STIMULATOR FAMILY. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rs Medical (Vancouver, US). The FDA issued a Cleared decision on June 13, 2002 after a review of 15 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 - K021763

510(k) Number K021763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2002
Decision Date June 13, 2002
Days to Decision 15 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
101d faster than avg
Panel avg: 116d · This submission: 15d
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.

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 505
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K021763.
POWERED MUSCLE STIMULATOR
K013768 · Theratech, Inc. · Jul 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · Apex Medical Corp. · Jun 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · Empi · Jun 2002
SELECT STIM
K020637 · Care Rehab and Orthopaedic · May 2002
FINESUN EMS STIMULATOR
K020684 · Finesun Worldwide Intl. Co., Ltd. · May 2002
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
K020314 · Well-Life Healthcare, Inc. · Apr 2002

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.

K021763 · RS2MI MUSCLE STIMULATOR FAMILY
Download PDF FDA Summary Rs Medical