Regulatory, Medical & Safety Information
Transparency, safety, and responsible use
Regulatory, safety and product information for GASTER control® — a CE-marked Class I medical device intended for support of the abdominal wall, with an integrated extra-parietal compression module.
Regulatory classification and manufacturer
5/1 Merchants Street, Valletta VLT 1171, Malta
Intended purpose and scope
In accordance with the instructions for use LLGC20251201 v.1, the device is intended for support of the abdominal wall in the following indications:
Abdominal hypotonia. Post-operative support of the abdominal wall, on medical prescription. Accompaniment of the recovery phase after abdominal surgery. Limitation of abdominal pressures during everyday physical exertion.
The device integrates a localised abdominal compression system by means of an inflatable extra-parietal balloon. Use of this function must strictly comply with the contraindications, precautions and operating instructions set out below and in the instructions for use.
Duration of use
In accordance with Annex VIII of Regulation (EU) 2017/745, the device is intended for short-term use: intermittent use during the day, with regular breaks. No continuous wear beyond 30 days.
When the device must not be used
- Pregnancy
- Patient under 18 years of age
- Morbid obesity (BMI above 40 kg/m²)
- Irreducible or unsupported abdominal hernia
- Immediate post-operative period without medical advice
- Severe gastro-oesophageal reflux, gastric ulcer or progressive digestive disease
- Cardio-respiratory or neurological conditions that may be aggravated by abdominal compression
- Diagnosed eating disorders
- Dermatoses or skin lesions in the area where the device is worn
- Any medical condition that may be aggravated by abdominal compression, including suspected abdominal aortic aneurysm
Safe use guidelines
- Verify the integrity of the device before each use
- Wear the belt over a thin garment — never directly on the skin
- Inflate the balloon progressively — never seek maximum compression. Maintain moderate, comfortable pressure. Stop immediately in case of pain, dyspnoea, nausea, dizziness or discomfort
- Do not use the device with the balloon inflated in a lying or semi-reclined position
- Do not use while driving a vehicle
- Do not use during intense physical activity or sudden movements
- Take regular breaks to avoid prolonged compression
- In case of redness, irritation, swelling, sensory disturbance or unusual skin reaction, remove the belt immediately and consult a healthcare professional
- The presence of ferromagnetic components makes the device incompatible with MRI — remove the device before any MRI examination
- Keep the belt and its accessories out of reach of children
- Consult a healthcare professional in case of medical doubt about using the compression function
Possible undesirable effects
Abdominal discomfort. Mild respiratory discomfort. Skin redness or irritation. Gastric reflux in sensitive individuals.
If any of these symptoms occur, remove the device immediately.
Engineering principles for safe use
Safety is integrated throughout the design, development and validation process. The risk management file is established in accordance with EN ISO 14971:2019 and covers hazardous situations under normal and abnormal conditions of use.
Risk management
Following implementation of risk control measures, all risks assessed as intolerable were eliminated. Residual risks are documented and assessed as acceptable in relation to the expected benefits, in accordance with the requirements of the Regulation.
Biocompatibility
Components in contact with or adjacent to the skin are evaluated in accordance with ISO 10993-1 for prolonged contact with intact skin. Biological endpoints addressed include cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10) and irritation (ISO 10993-23). The device is designed to be worn over a garment, minimising direct skin contact.
Mechanical validation
Performance testing covers inflation and deflation cycle durability, elastic band tension, hook-and-loop fastening strength, and mechanical wear assessment of the pump and balloon assemblies. Real-time ageing studies and use tests complement the validation programme.
Documentation status
A clinical evaluation has been conducted in accordance with Article 61 and Annex XIV of Regulation (EU) 2017/745, covering the intended purpose declared in the instructions for use.
A post-market surveillance system is in place in accordance with Article 83 of the Regulation. It is based on centralised collection of user feedback, systematic escalation of any incident, malfunction or complaint to the legal manufacturer, periodic analysis under the surveillance plan, and production of an annual report.
Cleaning, storage and traceability
Cleaning
Hand wash at 30°C maximum with mild soap. Rinse thoroughly and dry flat at room temperature. Do not use solvents, alcohol, bleach or abrasive detergents. Do not iron, machine dry or tumble dry. Allow to air dry flat.
Storage
Store between 10°C and 30°C. Keep away from humidity, heat, dust and direct sunlight.
Traceability and vigilance
Retain the device reference and lot number for all correspondence. In the event of an incident or serious undesirable effect related to use of the device, immediately inform the manufacturer and the competent authority of the Member State in which the user or patient is established.
Legal manufacturer — GASTER Technology Limited, office@gastertechnology.com
Proprietary technology
GASTER control® and the related biomechanical designs, including the Extra-Parietal Balloon (BEP™) technology, the compressive shield architecture and the associated engineering principles, are proprietary. Patent filed in France, with an IP strategy designed to support international extensions.
Unauthorised reproduction, imitation or use of protected elements is prohibited.
Conditions of use and limitations of liability
GASTER Technology Limited shall not be held responsible for use inconsistent with the instructions for use, misuse or inappropriate adaptation of the technology, or use outside the applicable professional, clinical or regulatory frameworks.
Technical specifications, intended purpose statements and regulatory information may evolve over time in accordance with product development, jurisdictional requirements and clinical documentation.
The content provided on this website is for informational purposes only. It does not constitute medical advice and does not replace professional medical evaluation or clinical decision-making. Always refer to the instructions for use supplied with the device, which remain the applicable reference document in all circumstances.
CE-marked Class I medical device — Regulation (EU) 2017/745. Intended for support of the abdominal wall. Supplied on medical prescription. Not reimbursed. Proprietary biomechanical design (patent pending).
Always refer to the full instructions for use, reference LLGC20251201 v.1, supplied with the device.