Cleared Traditional

K821449 - P6S ATHLETIC

K821449 is an FDA 510(k) clearance for P6S ATHLETIC, manufactured by Squire, Sanders & Dempsey. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K821449 · Squire, Sanders & Dempsey · Physical Medicine device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 1982

Decision

69d

Days

Class 2

Risk

K821449 is an FDA 510(k) clearance for the P6S ATHLETIC. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Squire, Sanders & Dempsey (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 69 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 - K821449

510(k) Number	K821449 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 1982
Decision Date	July 22, 1982
Days to Decision	69 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

47d faster than avg

Panel avg: 116d · This submission: 69d

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 529

Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K821449.

MYO-TONE, INC. SYSTEM-80

K822250 · Myo-Tone, Inc. · Sep 1982

COMPLY NEUROMUSCULAR STIMULATOR

K822284 · Omega-Med Intl., Inc. · Sep 1982

EF2000

K820953 · Squire, Sanders & Dempsey · Jul 1982

BX-1000 ISOMATIC

K820080 · Bloomex International, Inc. · Jul 1982

ELECTRONIC MUSCLE EXERCISER

K821110 · Bloomex International, Inc. · Jul 1982

HETERODYNAMIC

K821157 · Birtcher Corp. · Jun 1982

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.

Manufacturer of K821449

Squire, Sanders & Dempsey

Mchenry, IL · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Squire, Sanders & Dempsey →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 22, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026