Cleared Traditional

ActiPatch (K192234) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence.

K192234 · Bioelectronics Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
165d
Days
Class 2
Risk

K192234 is an FDA 510(k) clearance for the ActiPatch. Classified as Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain (product code PQY), Class II - Special Controls.

Submitted by Bioelectronics Corporation (Frederick, US). The FDA issued a Cleared decision on January 31, 2020 after a review of 165 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 Bioelectronics Corporation devices

Submission Details

510(k) Number K192234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date January 31, 2020
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PQY Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
Definition Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03542955 Completed Interventional Industry-sponsored

Pulse Shortwave Therapy in Cervical Osteoarthritis

The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib

180
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Cervical Osteoarthritis
Study design Parallel
Eligibility All sexes · 30 Years+
Principal investigator Rachid Mohammad, MD
Sponsor BioElectronics Corporation (industry)
Started 2018-05-01 → Primary completion 2019-07-30
Primary outcome
Neck Disability Index (NDI)
Secondary outcome
Visual Analog Scale (VAS)
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov