Last updated 28th March 2025 Document reference: MD-00002v15.0
This is regulatory information for patients using the Flok Health Clinical Engine.
Device name and model number: Flok Health Clinical Engine (CELBP1) Unique device identification: 35070002368305 Software version: 3.0.xx Release date: 2025-03-10
Flok Health Ltd
Manufacturer Address:
Lime Tree Barn Foxes Bridge Farm Royston Lane Comberton Cambridge CB23 7EE United Kingdom
Email address: [email protected]
Telephone number: 0333 3396 052
Website: https://flok.health/
2025-03-10
The Flok Health Clinical Engine is only compatible with the Flok Health App v1.0 onwards.
| Minimum hardware requirements | Smartphone or tablet |
|---|---|
| Operating system compatibility | Compatible with the Flok Health app |
| Internet access requirements | Yes |
| Minimum screen size | 4.7 inches diagonally |
| Languages supported by the device | British English |
The Flok Health Clinical Engine is a software medical device that delivers a digital pathway designed by a healthcare provider. It is intended to provide triage and rehabilitation therapy directly to a patient through a video and chat-based user interface.
The Flok Health Clinical Engine is intended for use by patients in their home environment as primary care without special equipment or instruction.
A patient watches videos that display physiotherapy content. At the end of each video a patient is asked questions with multiple choice answers. The physiotherapy content that the device delivers to the patient next depends on their response to each question and all the previous responses patients have given.
Indications
The Flok Health Clinical Engine is for patients with non-specific low back pain without sciatica, or non-specific low back pain with unilateral sciatica (sciatica with symptoms in down one side of the body only). These symptoms can be acute or chronic.
The Flok Health Clinical Engine is for lay people who are: