Cleared Traditional

K190251 - RecoveryRx

K190251 is an FDA 510(k) clearance for RecoveryRx, manufactured by Bioelectronics Corporation. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K190251 · Bioelectronics Corporation · Physical Medicine device
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Jun 2019
Decision
141d
Days
Class 2
Risk

K190251 is an FDA 510(k) clearance for the RecoveryRx. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Bioelectronics Corporation (Frederick, US). The FDA issued a Cleared decision on June 28, 2019 after a review of 141 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 Bioelectronics Corporation devices

FDA 510(k) Submission Details - K190251

510(k) Number K190251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2019
Decision Date June 28, 2019
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than 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 - ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

All 8
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