Cleared Traditional

K933611 - THE BTE WS30

K933611 is the FDA 510(k) clearance for THE BTE WS30 by Baltimore Therapeutic Equipment Co.. It is a Class 2 Physical Medicine device (product code ISD) cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K933611 · Baltimore Therapeutic Equipment Co. · Physical Medicine device
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Jun 1994
Decision
336d
Days
Class 2
Risk

K933611 is an FDA 510(k) clearance for the THE BTE WS30. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on June 20, 1994 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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. Elevated predicate reliance profile. 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 Baltimore Therapeutic Equipment Co. devices

Submission Details

510(k) Number K933611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date June 20, 1994
Days to Decision 336 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
221d slower than avg
Panel avg: 115d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 17
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