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Important notice
Effective July 21, 2026. Read this page together with the Terms of Use, Privacy Policy, current product labeling, authorized training, and patient-specific instructions from qualified professionals.
Medical and emergency limitations
Website content is general educational and business information. It does not establish a clinician-patient relationship and should not be used to diagnose a condition, select a patient, prescribe exercise, determine swallowing safety, change treatment, or replace individualized advice.
The website, account portal, email, and support channels are not emergency services. Call 911 or the appropriate local emergency number for signs of stroke, breathing difficulty, choking, severe allergic reaction, loss of consciousness, or another emergency.
A qualified professional must determine whether the device and a particular activity are appropriate after considering diagnosis, recovery stage, medical and surgical status, dentition, oral tissue, jaw function, pain, cognition, swallowing or airway concerns, and other patient-specific factors.
Product training does not create or expand a professional license. Providers must practice within their education, training, experience, licensure, facility policy, and applicable law, and must coordinate with other professionals when the patient’s needs cross disciplines.
Home use, if prescribed, requires an individualized setup, dosage, cleaning process, stopping criteria, and follow-up plan. Patients should not self-diagnose, independently increase resistance or volume, share the device improperly, or continue through unexpected symptoms.
Regulatory and product status
ISO Metrik states that it is seeking FDA clearance. The website must not be interpreted as representing that the device is FDA cleared, approved, certified, or authorized for a particular disease or indication unless a specific lawful authorization has been obtained and is accurately identified.
FDA establishment registration or device listing, if applicable, does not itself mean that a medical device has been cleared, approved, certified, or endorsed by FDA.
Product classification, availability, labeling, professional use, advertising, import, distribution, and regulatory requirements may differ by country, state, or other jurisdiction.
Current authorized labeling, instructions for use, contraindications, warnings, cleaning instructions, training requirements, and product communications control over general website descriptions when there is a conflict.
Product design, materials, accessories, training, intended use, evidence, regulatory status, availability, and pricing may change. Images and descriptions may show developmental or representative configurations.
Evidence and outcomes
Resistance-training principles, motor learning, facial exercise research, swallowing and speech literature, anatomy, Wolff’s Law, mechanobiology, and other related science may inform hypotheses and development. They do not automatically establish that ISO Metrik is safe or effective for a particular patient, disease, indication, or outcome.
Prospective device-specific research is needed to define safety, feasibility, dosage, patient selection, comparative effectiveness, durability, adverse events, and clinically meaningful outcomes for specified uses.
No improvement in strength, symmetry, speech, swallowing, expression, appearance, bone, muscle, skin, participation, recovery time, or quality of life is guaranteed. Natural recovery and many patient and treatment factors may influence change.
Illustrative milestones, case examples, testimonials, or projected timelines—if presented—are not promises. Response and appropriate reassessment timing vary by diagnosis, onset, severity, recovery stage, medical status, treatment, and adherence.
Images or examples may be affected by lighting, angle, expression, camera, timing, natural recovery, concurrent care, and other factors. They should not be treated as typical or guaranteed results without adequate context.
Coverage, coding, and financial information
Coverage depends on the patient’s benefit plan, payer policy, network, provider contract, diagnosis, setting, service, authorization, medical necessity, documentation, and other requirements. Verification is not a guarantee of payment.
The device name does not determine a billing code. Providers and billers must code the actual service delivered and follow current payer, professional, contractual, and legal requirements. ISO Metrik does not provide a binding coding determination.
Deductibles, copayments, coinsurance, noncovered services, authorization failures, denials, and other amounts may be the patient’s responsibility depending on the plan and clinic policies.
Market size, patient volume, pricing, revenue, commission, referral, growth, or return examples are illustrative assumptions unless expressly identified otherwise in an authorized agreement. Actual results depend on demand, operations, costs, competition, compliance, collections, payer mix, and other risks.
Website content is not investment, tax, legal, accounting, employment, patent, regulatory, coding, or reimbursement advice. Obtain qualified advice for decisions in those areas.
Third parties and communications
Links to agencies, articles, professional organizations, clinics, maps, identity providers, or other third parties are provided for context or convenience. A link does not mean the third party endorses ISO Metrik, and ISO Metrik does not control the third party’s content or practices.
Participating clinics and providers are responsible for their own professional services, employment, licensing, records, billing, privacy, patient communication, facilities, and legal obligations unless a written agreement states otherwise.
Statements from founders, providers, patients, partners, employees, or other individuals reflect their perspectives and do not replace controlled research, regulatory review, payer policy, or a patient-specific clinical assessment.
ISO Metrik may correct, update, remove, or replace website content as information, product status, evidence, or requirements change. Users should verify time-sensitive information directly with the appropriate authority or professional.
Questions about product information or this disclaimer may be sent to info@isometrik.com. Do not use general email for emergencies, passwords, complete medical records, or unnecessary sensitive information.
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