The Effectiveness of Sustained Heat Treatment on Delayed-Onset Muscle Soreness (DOMS)

Inclusion Criteria:

• Any gender and any ethnic origin, aged between 18 and 55 years (inclusive), in goodgeneral health and able to perform and complete the exercise regimen.
• No significant physical activity causing DOMS in the thighs/quads in the past 4 weeks. Body mass index <40 kg/m2.
• No clinically relevant cardiovascular disease, hepatic disease, diabetes, lower limbneuropathies or recent lower limb injuries.
• Normal blood pressure (systolic blood pressure 90 to 140 mmHg, diastolic bloodpressure 60 to 90 mmHg, inclusive) at rest.
• Subject is either not of childbearing potential (defined as biological male sex orpostmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation,bilateral oophorectomy, or hysterectomy]) and must agree not to start a pregnancy fromthe signature of the informed consent up to the final visit or practicing one of thefollowing medically acceptable methods of birth control:

1. Hormonal methods such as oral, implantable, injectable, or transdermalcontraceptives for a minimum of 1 full cycle (based on the subject's usualmenstrual cycle period) up to the final visit
2. Total abstinence from sexual intercourse since the last menses before exposure tothe device and up to the final visit
3. Intrauterine device
4. Double-barrier method (condoms, sponge, diaphragm, with spermicidal jellies orcream) up to the final visit -----Must have personal smartphone (i.e., iOS orAndroid).

• Capable of returning to the investigation center for all the visits according torequirement of CIP.
• Willing to comply with the policy, procedure, and restriction of the investigation.
• Capable of actively communicating with the investigator.
• Capable of completing the investigation-related documents.
• Capable of understanding the contents of the informed consent and personal dataprocessing consent and legally ---capable of signing a written informed consent and apersonal data processing consent prior to any investigation-related procedures.

Exclusion Criteria:

• Skin lesions (e.g., rash, bruising, laceration) in the thigh region, or spreading skinconditions (e.g., poison ivy, urticaria) in other regions, or any skin abnormalitylikely to be aggravated by the device such as dermatological disease or infection,rash, atrophic, fragile or abnormally dry skin, cuts or abrasions at the treatmentsite.
• Clinically significant abnormalities at medical history and/or physical examination atVisit 1, which in the opinion of the investigator could interfere with theinvestigation procedures or endpoint evaluations.
• Treatment with alpha or beta agonists/antagonists, any type of anti-inflammatory oranalgesic medications, Cox-2 inhibitors, calcium channel blockers, pregabalin (Lyrica), other pain reducers, muscle relaxants, creatine, ephedrine orpseudoephedrine.
• Lactating or pregnant women.
• Suspected or confirmed coronavirus disease 2019 infection at Visit 1.
• History of (within the past 12 months) or current alcohol or substance abuse.
• Any history of radiculopathy and neurological deficits.
• Vulnerable subjects (i.e., individuals who are unable to fully understand all aspectsof the investigation that are relevant to the decision to participate, or who could bemanipulated or unduly influenced as a result of a compromised position, expectation ofbenefits or fear of retaliatory response).
• Subjects who have participated in another interventional investigation within the past 30 days before enrollment or are currently participating in another non-interventionalinvestigation which might impact the outcome of this investigation.
• Subjects who are involved in the conduct of the investigation (i.e., investigator orhis/her deputy, first grade relatives, pharmacist, assistant or other personnel).
• Known skin hypersensitivity to adhesion products.
• Any other condition that, in the opinion of the investigator, interferes with theinvestigation endpoints/procedures and does not justify the inclusion of the subjectin the investigation.