Cleared Traditional

K022998 - HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312

K022998 is an FDA 510(k) clearance for HOME CARE VAREIOUS MODELS OF POWERED MU..., manufactured by Home Care Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K022998 · Home Care Technology Co., Ltd. · Physical Medicine device
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May 2003
Decision
253d
Days
Class 2
Risk

K022998 is an FDA 510(k) clearance for the HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Home Care Technology Co., Ltd. (Columbus, US). The FDA issued a Cleared decision on May 20, 2003 after a review of 253 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Home Care Technology Co., Ltd. devices

FDA 510(k) Submission Details - K022998

510(k) Number K022998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date May 20, 2003
Days to Decision 253 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 115d · This submission: 253d
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 236
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K022998.
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K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002