Functional Change With MMS

• The ZELTIQ System (Device): The MMS device will be used to perform the treatments.

Primary outcomes

• Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit [Baseline, 1-month post-treatment follow-up visit]: Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region (abdomen). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
• Number of Incidents of Device-Related Adverse Events [AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment (approximately 4 months).]: The incidence of device-related adverse events (AE) including device-related serious AEs will be tabulated.

Sex: All, ages: 22 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria

* Subject (healthy volunteer) has read and signed the study written informed consent form.
* Male or female ≥ 22 years and ≤65 years of age.
* Subject has not had weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine during the course of the study.
* Subject has a BMI ≤ 30 as determined at screening.
* Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
* Subject agrees to refrain from any new abdominal muscle training exercises of the treatment area during the course of the study.

Exclusion Criteria

* Subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process.
* Subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has had an intrauterine contraceptive device inserted or removed within the past month.
* Subject has a bleeding disorder or hemorrhagic condition
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system.
* Subject has metal or electronic implants in or adjacent to the treatment area
* Subject has an abdominal hernia.
* Subject has pulmonary insufficiency.
* Subject has a cardiac disorder.
* Subject has a malignant tumor.
* Subject has been diagnosed with a seizure disorder such as epilepsy.
* Subject currently has a fever.
* Subject is diagnosed with Grave's disease.
* Subject has a growth plate in the treatment area
* Subject is pregnant or intending to become pregnant during the study period (in the next 9 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Participant flow

Outcome results

• Change in Body Satisfaction Questionnaire From Baseline to 1-month Post-Treatment Follow-up Visit (Primary), Mean, units on a scale: Magnetic Muscle Stimulation (MMS) Treatment Group 8.6 +/- 5.4
• Number of Incidents of Device-Related Adverse Events (Primary), Number, Device-Related Adverse Events: Magnetic Muscle Stimulation (MMS) Treatment Group 1

Adverse events

Time frame: Adverse event data was collected from the time of enrollment through the 4-week post final treatment follow-up visit, approximately 4 months.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-01-29)