Cleared Traditional

K990813 - REHCOR

K990813 is an FDA 510(k) clearance for REHCOR, manufactured by Electromed Corp.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K990813 · Electromed Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
32d
Days
Class 2
Risk

K990813 is an FDA 510(k) clearance for the REHCOR. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Electromed Corp. (Deerfield, US). The FDA issued a Cleared decision on April 12, 1999 after a review of 32 days - a notably fast clearance cycle.

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: 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 Electromed Corp. devices

FDA 510(k) Submission Details - K990813

510(k) Number K990813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date April 12, 1999
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K990813.
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