Bioelectronics Corp (BIEL)

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SIMPLE: FDA-U.S.-Food-and-Drug-Administration-(Actipatch-clearance-information for OTC with links to FDA websites JUST FACTS)

510(k) Premarket Notification

Device Classification Name Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
510(K) Number K152432
Device Name ActiPatch(R)
Applicant
BIOELECTRONICS CORPORATION
4539 Metropolitan Court
Frederick, MD 21704
Applicant Contact Andrew Whelan
Correspondent
BIOELECTRONICS CORPORATION
4539 Metropolitan Court
Frederick, MD 21704
Correspondent Contact Andrew Whelan
Regulation Number 890.5290
Classification Product Code
PQY
Date Received 08/27/2015
Decision Date 02/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed By Third Party No
Combination Product No
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Page Last Updated: 06/19/2017

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152432

FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Contact FDA

FDA, U.S. Food and Drug Administration

The information on this page is current as of April 1 2016.

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2016]
[CITE: 21CFR890.5290]
See Related Information on Shortwave diathermy. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart F--Physical Medicine Therapeutic Devices

Sec. 890.5290 Shortwave diathermy.
(a) Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions --(1) Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

(2) Classification. Class II (performance standards).

(b) Nonthermal shortwave therapy --(1) Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.

(2) Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:

(i) Components of the device that come into human contact must be demonstrated to be biocompatible.

(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.

(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:

(A) Peak output power;

(B) Pulse width;

(C) Pulse frequency;

(D) Duty cycle;

(E) Characteristics of other types of modulation that may be used;

(F) Average measured output powered into the RF antenna/applicator;

(G) Specific absorption rates in saline gel test load or other appropriate model;

(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and

(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.

(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.

(v) Labeling must include the following:

(A) Output characteristics of the device;

(B) Recommended treatment regimes, including duration of use; and

(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.

(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.

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Page Last Updated: 09/21/2016
FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Contact FDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5290

FDA, U.S. Food and Drug Administration

Device Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Regulation Description Shortwave diathermy.
Definition Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Physical State Nonthermal shortwave therapy devices which include applicators applied to the body.
Technical Method Uses pulsed electromagnetic energy at 13.56 MHz or 27.12 MHz delivered treatment.
Target Area To be applied over body areas and joints such as the knee and ankle; however, the device should not be applied directly over areas with active implantables.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product Code PQY
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
Submission Type 510(k)
Regulation Number 890.5290
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible

FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Contact FDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=5021