The ActiPatch remains the only PSWT/PEMF FDA Cleared Medical Device to be authorized for Over the Counter sales in the US. Every other PSWT/PEMF device sold OTC is not a 'Medical Device', they are 'Wellness Products' which can not make any claims to treat any Medical Condition.
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Page Type - Product Code
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
Submission Type - 510(K)
Device Classification - Class 2
Regulation Number - 890.5290
GMP Exempt? - No
Summary Malfunction Reporting - Ineligible
Implanted Device - No
Life-Sustain/Support Device - No
Third Party Review - Not Third Party Eligible
MAUDE Alerts - View and Sign Up For MAUDE Alerts
CFR § 890.5290 Shortwave diathermy
§ 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;
(
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;
( 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.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 80 FR 61302, Oct. 13, 2015]
https://fda.innolitics.com/submissions/PM/sub...evices/PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Page Type - Product Code
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
Submission Type - 510(K)
Device Classification - Class 2
Regulation Number - 890.5290
GMP Exempt? - No
Summary Malfunction Reporting - Ineligible
Implanted Device - No
Life-Sustain/Support Device - No
Third Party Review - Not Third Party Eligible
MAUDE Alerts - View and Sign Up For MAUDE Alerts
CFR § 890.5290 Shortwave diathermy
§ 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;
(
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;
(
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.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 80 FR 61302, Oct. 13, 2015]
https://fda.innolitics.com/submissions/PM/sub...evices/PQY
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