Cleared Traditional

K022493 - EMS 400

K022493 is an FDA 510(k) clearance for EMS 400, manufactured by Body Clock Health Care, Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K022493 · Body Clock Health Care, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
74d
Days
Class 2
Risk

K022493 is an FDA 510(k) clearance for the EMS 400. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Body Clock Health Care, Ltd. (London, England, GB). The FDA issued a Cleared decision on October 11, 2002 after a review of 74 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 Body Clock Health Care, Ltd. devices

FDA 510(k) Submission Details - K022493

510(k) Number K022493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 11, 2002
Days to Decision 74 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
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 167
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K022493.
SYS*STIM 208 AND 208A
K031017 · Mettler Electronics Corp. · May 2003
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K021588 · Biomedical Life Systems, Inc. · Feb 2003
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K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
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K014019 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · Apex Medical Corp. · Jun 2002
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K021100 · Empi · Jun 2002