Class I medical device
Instructions for Use
Date of issue: 20 May 2026 · Document version: 1.3
Important information
- Compatibility
- Internet-capable smartphone with Apple iOS 15.0 or newer, internet access, minimum 200 MB storage, email address for account registration, and functioning front camera for optional AR-based mouth-opening measurement.
- CE marking
- The JawBuddy app is a Class I medical device under the European Medical Device Regulation MDR (EU) 2017/745.
- Product name
- JawBuddy
- App version
- 2.0.0
- GLN
- 4262590960003
- GS1 Company Prefix
- 426259096
- Basic UDI-DI
- 04262590960003
- UDI-DI v2.0.0
- 04262590960010
- Applies to
- JawBuddy app v2.0.0
- IFU version
- 1.3, issued 20 May 2026
- Web version
- https://jawbuddy.com/medical-device/instructions-for-use
Manufacturer address
JawBuddy UG (haftungsbeschränkt)
Nobelstraße 10
70569 Stuttgart
Germany
Email: support@jawbuddy.com
Person Responsible for Regulatory Compliance (PRRC): Moritz Scherer (mdr@jawbuddy.com)
JawBuddy Instructions for Use
These Instructions for Use are intended for the correct application of the JawBuddy app. Please read this information carefully and follow the instructions contained herein. For any questions, contact our support team by email at support@jawbuddy.com.
Intended purpose
The JawBuddy app supports and enables adult users (18+) in the independent performance of evidence-based exercise therapy for the relief of discomfort in the jaw, neck, and head region, in particular in the following conditions:
- Bruxism (F45.82)
- Pain in the temporomandibular joint and disorders of the temporomandibular joint, including craniomandibular dysfunction (K07.63, K07.69)
- Myalgia of the head-neck region (M79.10)
Additional information
- The exercise program is based on current scientific literature on conservative exercise therapy.
- The app provides structured exercise instructions, self-tracking functionalities, and educational content.
- The minimum age for use of the JawBuddy app is 18 years.
How it works
JawBuddy is an interactive smartphone app for independent self-application. After registration, your password-protected account in the JawBuddy app is available at any time.
The app includes the following main functions:
- Structured onboarding with safety screening, intended-use acknowledgement, and selection of your primary discomfort region (jaw, neck, head)
- Flexible exercise program consisting of self-massage, mobilisation, strengthening, and stretching exercises as well as relaxation techniques
- Video instructions with visual animations and picture-in-picture mirroring of the front camera for self-check of execution
- Four predefined difficulty levels per exercise; all users start at level 2 of 4. The level adapts based on your feedback after each exercise (too easy / just right / too difficult)
- Optional AR-based mouth-opening measurement via the smartphone front camera for your personal progress documentation
- Self-tracking of pain, stress, and physical tension
- Educational content on anatomical fundamentals, bruxism, stress management, and ergonomics
Exercise plan
- You choose the days on which you complete an exercise session.
- Each session lasts approximately 15 minutes.
- We recommend at least four sessions per week.
- The app provides a literature-based exercise repertoire.
- From day 11 onward, the selection is adapted within a predefined exercise repertoire and your chosen complaint region based on your ratings.
Indications
Use of the JawBuddy app is indicated for:
- Bruxism (F45.82)
- Pain in the temporomandibular joint and disorders of the temporomandibular joint, including CMD (K07.63, K07.69)
- Myalgia of the head-neck region (M79.10)
- The minimum age for use of the JawBuddy app is 18 years.
Contraindications
The JawBuddy app must not be used, or only after consultation with a physician, in the following cases:
- Other conditions not listed here may also be unsuitable for the use of the JawBuddy app.
- Before use, it is recommended to have your physician or dentist confirm that the physical exercises as used in the JawBuddy app can be performed safely.
Absolute contraindications
- Acute trauma or dislocation of the temporomandibular joint
- Locked jaw (complete inability to open or close the mouth)
- Sudden, unexplained pain without recognisable cause
- Facial numbness or paresthesia
- Persons under 18 years of age
Relative contraindications (require medical clearance before use)
- Rheumatoid arthritis or autoimmune joint disorders affecting the temporomandibular region
- Neurological conditions (e.g., trigeminal neuralgia, multiple sclerosis, central pain syndromes)
- Fibromyalgia or chronic pain syndromes
- Tumors or active infections in the facial, jaw, or oral region
- Active oncological treatment in the head and neck region
- History of temporomandibular joint surgery without medical clearance
- Recent dental surgery or oral surgical procedure within the last 8 weeks
- Active CMD requiring primary medical or dental intervention
- Severe malocclusion requiring orthodontic treatment
- Conditions where light physical exercise causes dizziness, pain exacerbation, or balance issues
Frequency of use
The JawBuddy app therapy program is designed for regular use, with each session lasting approximately 15 minutes. Recommended frequency: 4 sessions per week.
Safety information and side effects
JawBuddy does not replace a physician, dentist, or therapist. Any change in existing medications or treatments must not be made without consultation with your treating physician. For acute pain or changes, contact your physician immediately.
Follow the instructions of your physician/dentist/therapist regarding the exercises and movements that you may perform in your specific health condition. Your physician's instructions always take priority over the app's instructions.
Before performing any exercise, carefully observe the instructions in the video and read the explanatory text. Stop the exercise and consult your physician or therapist if you are unsure. Incorrect execution can lead to pain or injury.
Answer the questions asked in the app carefully and truthfully, particularly regarding pain, movement limitations, and contraindicated medical conditions. Inaccurate information may lead to exercises being assigned that are not suitable for you.
The AR-based mouth-opening feature is not a measurement function in the regulatory sense and does not provide diagnostically usable values. It is intended solely for personal progress observation; specific millimeter values are subject to substantial variation due to lighting, camera position, and smartphone model. It does not replace clinical measurement by a qualified professional. Do not use the values to make clinical decisions or to delay medical advice.
If clicking, crepitus, or pain increases during exercise execution, stop the exercise and consult a qualified healthcare professional.
As of the issue date, no adverse effects are known to the manufacturer in connection with the intended use of the JawBuddy app.
Product lifetime
The JawBuddy app is continuously maintained and updated. Product lifetime is tied to the app's availability in the Apple App Store and to ongoing support of the minimum iOS version (currently iOS 15.0). Should the lifecycle end, users will be notified in good time within the app and by email.
Updates and maintenance
Updates are delivered automatically via the Apple App Store. No user maintenance is required. For security-relevant updates a prompt is displayed on app launch; using newer functionality may require updating.
Disposal and uninstallation
The JawBuddy app can be uninstalled at any time via normal smartphone app management. After account deletion, your personal data will be deleted in accordance with our Privacy Policy. Separate disposal of physical components does not apply, as JawBuddy is software only.
Cybersecurity
Protect your JawBuddy account: use a strong, unique password and lock your smartphone with passcode, Touch ID, or Face ID. If you suspect unauthorised access to your account, contact us immediately by email at support@jawbuddy.com.
Access to these Instructions for Use
These Instructions for Use are accessible at any time within the app under "Profile -> About". The current web-based version is available at https://jawbuddy.com/medical-device/instructions-for-use. Previous versions of the Instructions for Use are kept available at https://jawbuddy.com/ifu.
On written request, we will provide a free printed or electronic copy by email to support@jawbuddy.com (delivery within 7 calendar days, in line with Commission Implementing Regulation (EU) 2021/2226).
Reporting adverse effects
Should adverse effects or incidents occur in connection with the use of JawBuddy, report these immediately to your physician and contact us by email at mdr@jawbuddy.com.
For serious incidents, please report the incident without delay to mdr@jawbuddy.com. You may also report serious incidents directly to the competent authority. JawBuddy UG assesses reported incidents and reports them to the competent authority where legally required.
In emergencies (e.g., acute pain, sudden neurological symptoms), contact your physician immediately or call an emergency number:
- Germany: 112 (emergency services), 116 117 (medical on-call service)
- Austria: 144 (emergency services)
- Switzerland: 144 (emergency services)
App download instructions
You can download the JawBuddy app from the Apple App Store. The process is the same as for any other app. If you experience any issues during download, send us an email at support@jawbuddy.com.