Cleared Traditional

K980448 - MODEL PS-1 PENA MUSCLE STIMULATOR

K980448 is an FDA 510(k) clearance for MODEL PS-1 PENA MUSCLE STIMULATOR, manufactured by Radionics, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K980448 · Radionics, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
57d
Days
Class 2
Risk

K980448 is an FDA 510(k) clearance for the MODEL PS-1 PENA MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 57 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.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K980448

510(k) Number K980448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1998
Decision Date April 03, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - IPF Stimulator, Muscle, Powered

All 272
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K980448.
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · Alive, Inc. · May 1998
HAKOMED ELECDT/VACUPULLS
K980958 · Alive, Inc. · May 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · Universal Technology Systems, Inc. · Apr 1998
STELLAR MODEL HS-04
K973223 · Stellar Medical Corp. · Feb 1998
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · Dan Med, Inc. · Nov 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · Skylark Device Co., Ltd. · Oct 1997