Cleared Traditional

K850573 - CURAMED 402

K850573 is an FDA 510(k) clearance for CURAMED 402, manufactured by Fluidotherapy Corp.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K850573 · Fluidotherapy Corp. · Physical Medicine device
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May 1985
Decision
93d
Days
Class 2
Risk

K850573 is an FDA 510(k) clearance for the CURAMED 402. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Fluidotherapy Corp. (Houston, US). The FDA issued a Cleared decision on May 17, 1985 after a review of 93 days - within the typical 510(k) review window.

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 Fluidotherapy Corp. devices

FDA 510(k) Submission Details - K850573

510(k) Number K850573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1985
Decision Date May 17, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
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 30
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K850573.
RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC
K862469 · Rich-Mar Corp. · Jul 1986
CURAMED 402 DIATHERMY UNIT
K861247 · Henley Intl. · May 1986
CURAPULS 419 DIATHERMY UNIT
K861248 · Henley Intl. · May 1986
ULTRAMED 11S601
K842801 · Robert Bosch Corp. · Aug 1984
SIEMENS ULTRATHERM 708
K781455 · Elmed, Inc. · Dec 1978
SHORTWAVE DIATHERMY MODEL 802
K780755 · Birtcher Corp. · May 1978