Clear answers for providers, clinics, and patients.

A provider-directed intraoral facial resistance platform using a bite plate, glide bar, lip holders, and interchangeable resistance components.

The provider may use isometric, isotonic, and provider-paced isokinetic-style exercise concepts. The selected mode, position, resistance, repetitions, hold time, rest, tempo, and frequency are individualized.

The platform is designed around facial and perioral resistance activities. The exact movement and target depend on the patient’s findings, functional goal, provider scope, and the approved instructions and training.

An appropriately qualified provider should review the diagnosis, recovery stage, medical and dental factors, tissue status, pain, swallowing or airway concerns, cognition, tolerance, and functional goal before prescribing use.

Active resistance should not be introduced during flaccid paralysis unless an appropriately qualified clinician determines that it is safe and indicated. Early priorities may include medical management, eye protection, education, observation, and prevention of harmful compensation.

A qualified clinician may consider selected use as part of a plan emphasizing selective motor control and avoidance of unwanted co-contraction. Resistance should not be increased when it worsens synkinesis or movement quality.

No. The device is an adjunct within a provider-directed plan. It does not replace examination, diagnosis, clinical reasoning, task-specific treatment, swallowing assessment, motor-speech therapy, referral, or follow-up.

A qualified provider may prescribe home use after screening, fitting, supervised practice, and teach-back. Patients should use only the assigned configuration and should not independently change resistance, range, repetitions, position, or frequency.

Users must follow the current product and clinic cleaning, drying, storage, inspection, and replacement instructions. A device should not be shared or reused in a manner that conflicts with those instructions or infection-control policy.

Stop and follow the clinic’s guidance for pain, bleeding, oral injury, jaw locking, significant irritation, increased spasm, unexpected weakness, dizziness, breathing or swallowing difficulty, or a damaged or poorly fitting component. Emergency symptoms require emergency care.

There is no guaranteed timeline. Response varies with diagnosis, severity, recovery stage, comorbidities, adherence, treatment selection, and natural recovery. Providers should use scheduled reassessment rather than promise a specific result by a specific date.

Durability of change has not been established for every use or population. Ongoing function may depend on the underlying condition, continued practice, medical status, and the maintenance plan selected by the treating provider.

Eligibility depends on the training program, professional credentials, competence, scope of practice, applicable law, and clinic policy. Completion of product training does not create or expand a professional license.

Certification documents completion of applicable ISO Metrik training and competency requirements at a point in time. It does not guarantee clinical outcomes, payer coverage, sales, referrals, or permission to practice outside professional scope.

Training addresses relevant anatomy and mechanics, resistance principles, device components, screening, fitting, operation, sanitation, safety, dosage, measurement, documentation, home-use decisions, scope, claims, and clinic implementation.

The clinic registers, identifies clinical and operational leads, enrolls participating providers, completes training, establishes screening and documentation workflows, prepares inventory and sanitation systems, and begins with a controlled launch.

The provider account is tied to an individual professional profile. The clinic account represents an organization and its implementation information. Use the account type that matches who owns and is responsible for the submitted profile.

Marketing must align with the device’s current regulatory status, authorized labeling, available evidence, provider scope, and applicable law. Clinics should not imply FDA clearance or disease-treatment claims that have not been authorized.

No. Referral volume depends on relationships, geography, patient need, clinical quality, payer and provider factors, marketing compliance, and many other variables.

The record should include screening, baseline findings, goals, skilled rationale, device setup, resistance and dosage, cueing, tolerance, response, objective comparison, functional progress, home instructions, and the plan for progression, referral, or discharge.

Stop using a questionable component and follow the clinic and ISO Metrik reporting pathway. Include the product details, what happened, when it happened, patient or user effect, action taken, and current status without sending unnecessary protected information.

Open the provider and clinic portal for the correct account pathway. When requesting support, include the organization, account email, role, affected page or workflow, and a concise problem description. Never send a password.

The website should not imply clearance or approval that has not been obtained. ISO Metrik states that it is seeking FDA clearance. FDA registration or device listing, if applicable, would not by itself mean a device is cleared or approved.

The rationale draws on established rehabilitation principles and related facial exercise literature. Related evidence does not establish device-specific safety or effectiveness. Prospective ISO Metrik studies are needed for specific populations, protocols, and claims.

No. Research on other exercises or therapy programs can inform clinical questions but cannot be treated as direct proof that this device produces the same outcomes.

Coverage is not guaranteed. It depends on the benefit plan, payer policy, provider contract, diagnosis, setting, service delivered, coding, authorization, medical necessity, and documentation.

The device name does not determine a billing code. The clinic must code the actual skilled service delivered and follow payer-specific requirements. ISO Metrik does not guarantee that any particular code is appropriate or payable.

No. Natural recovery, diagnosis, severity, timing, medical status, technique, adherence, provider decisions, and other factors influence outcomes.

No. Financial examples are illustrative only. Patient volume, referrals, pricing, collections, costs, payer mix, and profitability vary and require independent business and legal review.

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