Cleared Traditional

K964083 - ULTRATHERM (908)

K964083 is an FDA 510(k) clearance for ULTRATHERM (908), manufactured by Sie-Med, Inc.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K964083 · Sie-Med, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
174d
Days
Class 2
Risk

K964083 is an FDA 510(k) clearance for the ULTRATHERM (908). Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Sie-Med, Inc. (Clarksville, US). The FDA issued a Cleared decision on April 3, 1997 after a review of 174 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Sie-Med, Inc. devices

FDA 510(k) Submission Details - K964083

510(k) Number K964083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date April 03, 1997
Days to Decision 174 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
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 25
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K964083.
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