Information for patients

Device manufacturer Information

Flok Health Ltd
Manufacturer Address:
Lime Tree Barn
Foxes Bridge Farm
Royston Lane
Comberton
CambridgeCB23 7EE
United Kingdom
Email address: regulatory@flok.health
‍Telephone number: 0333 3396 052
Website: https://flok.health/

2025-04-03

Device specifications and compatibility

• Minimum hardware requirements: Smartphone or tablet
• Operating system compatibility: Compatible with the Flok Health app
• Internet access requirements: Yes, Minimum 3 Mbps
• Minimum screen size: 4.7 inches diagonally
• Languages supported by the device: British English
• Device Lifetime: 5 years from manufacture

Intended Purpose

How the Flok Health Clinical Engine works

Indications

Intended patient population

• Aged 18+.
• Currently experiencing lower back pain or experience bouts of lower back pain.
• Able to move independently between standing, seated and lying positions (including from the floor).

Device Benefits and Performance Characteristics

Residual Risk

Contraindications

• Have significant cardiac disease.
• Have a bleeding diathesis, e.g., haemophilia.
• Are pregnant (any gestation).
• Have an underlying chronic neuromuscular disorder that affects their ability to perform light to moderate exercise (unless their doctor has advised that they are suitable).

Precautions

• Use the Flok Health Clinical Engine in distraction-free environment as distractions might lead to you accidentally answering a question incorrectly. This could mean that you might not receive appropriate and timely care which could lead to health complications.
• Always use a safe and clutter-free environment for physiotherapy exercises. Make sure you have enough space to move around safely, including being able to lie flat on the floor.
• Use the Flok Health Clinical Engine in a suitably private environment to protect the confidentiality of your personal healthcare information. If you are not in a private environment, there is a risk that you could be overheard or the information on the screen could be overseen.
• Only you should use your Flok Health Clinical Engine account. Allowing other people to use your account could result in exposure of your personal healthcare data.
• To use the Flok Health Clinical Engine safely, you must have good enough eyesight to see your smartphone clearly and good enough hearing to hear the audio content clearly.
• You must not have any not have cognitive impairment when using the Flok Health Clinical Engine.
• Do not attempt or continue with rehabilitation exercises that you are unable to do due to the risk of injury.
• You must not use the Flok Health Clinical Engine under the influence of alcohol, illegal drugs or other illicit substances.

Warnings

• To use the Flok Health Clinical Engine, you must be comfortable using smartphone or tablet mobile applications.
• While performing physiotherapy exercises there is a risk of injury due to falls, slips or trips and if you are taking oral anticoagulant therapy, e.g., warfarin, apixiban, rivoroxaban there is a risk of bleeding if you sustain an injury.
• To reduce the risk of falls, slips or trips during physiotherapy exercises, before each session remove all trip hazards from the immediate area around you and make sure you are wearing appropriate clothing and footwear.
• You must answer all questions asked by the device accurately, honestly and to the best of your knowledge. This is to reduce your risk of harm. Inaccurate answers may result in the device delivering an inappropriate treatment or advice.
• If you have an underlying breathing disorder such as asthma or COPD, there is a risk that you may experience an acute episode of breathlessness during the physiotherapy exercises.
• Contact your healthcare provider if you need more information or advice on using the Flok Health Clinical Engine but do not delay seeking further medical advice from an alternative provider if you are concerned about your symptoms.
• If you are concerned about your symptoms at any point while using the Flok Health Clinical Engine, you should seek additional medical advice from a healthcare professional such as a GP or via NHS 111.
• If you stop using the Flok Health Clinical Engine before you are discharged, or you do not do the physiotherapy sessions on a regular basis your recovery may be delayed, and your symptoms may persist longer than if you had completed the programme through to discharge.
• If you have a slow Wi-fi connection or slow mobile data network speed, the Flok Health Clinical Engine might not work properly. For example, videos might not load or play. If this happens, try using the Flok Health Clinical Engine in a different location or on a different Wi-fi connection, or alternatively, seek treatment from another healthcare professional such as your GP or NHS 111.

Side effects

• Increased pain (approximately 58 people in 100 people experience this)
• Muscle soreness (approximately 18 people in 100 people experience this)
• Unpleasant sensations like pins and needles or cracking sensations in your back (approximately 13 people in 100 people)
• Headaches (approximately 5 people in 100 people experience this)
• Dizziness (approximately 3 people in 100 people experience this)
• Sleep disturbance (approximately 2 people in 100 people experience this)

Reporting side effects

Device disclaimers

• Flok Health Ltd holds no responsibility for injury to patients should they progress to high level physiotherapy content by not undertaking earlier stage exercises.
• Flok Health Ltd holds no responsibility if patients ignore the clinical advice provided by the Flok Health Clinical Engine e.g., to seek alternate urgent medical provision.
• Flok Health Ltd holds no responsibility if patients fail to complete triage, physiotherapy treatment or withholds medical information such as symptoms from the Flok Health Clinical Engine.
• Flok Health Ltd holds no responsibility for injury, harm or data breach if the Flok Health Clinical Engine is used by a third person other than the registered patient regardless of whether the registered patient gave permission.
• Flok Health Ltd holds no responsibility if the requirements of the appropriate use environment for the Flok Health Clinical Engine for the patient and healthcare practitioner are not followed.
• Flok Health Ltd holds no responsibility if the requirements defined in the intended purpose are not followed.
• Flok Health Ltd holds no responsibility if the requirements for patient and healthcare practitioners are not followed.

How to report serious incidents

Patient Information

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