For Healthcare Professionals
An abdominal support belt with an integrated extra-parietal compression module
GASTER control® is a CE-marked Class I medical device intended for support of the abdominal wall. Supplied on medical prescription, fitted by orthotic specialists and pharmacists.
Classification and applicable reference document
GASTER control® (reference GSTR_LIPOLINE01) is a Class I medical device, CE-marked in accordance with Regulation (EU) 2017/745. The classification results from the application of Rule 1 of Annex VIII (non-invasive device). The full analysis of Rules 1 to 22 is documented in the technical file and concludes unambiguously in favour of Rule 1.
The device is non-invasive (it does not cross any orifice or surface of the body), non-active within the meaning of the Regulation (no energy source other than the manual pressure applied by the user via the integrated pump), non-sterile, reusable and non-implantable.
Composition and mechanical principle
The device consists of the following components:
A textile abdominal support belt, adjustable by hook-and-loop closure.
An integrated compression module, consisting of an extra-parietal inflatable
pocket positioned within the structure of the belt.
A ventral manual pump, allowing progressive inflation without electrical supply.
A manual deflation valve.
The device contains no electronic component, no embedded energy source and no integrated medicinal substance.
Mechanical principle
Progressive inflation of the balloon generates a localised external pressure on the abdominal wall. This pressure is strictly mechanical: it results solely from the increase in volume of the balloon within the belt and from the transmission of that pressure to the facing abdominal area. The level of compression is adjustable by the user and immediately releasable.
The device has no pharmacological, immunological or metabolic action. It delivers no substance, does not penetrate the body, does not modify the biological or chemical composition of tissues, and produces no energy.
Anatomical positioning
The compression module is positioned over the epigastric region, below the rib cage. Correct positioning is identified by aligning the sewn marker on the belt with the xiphoid process of the sternum. The device is worn over a thin garment and is never applied directly to the skin.
Indications according to the instructions for use
In accordance with the instructions for use LLGC20251201 v.1, GASTER control® is intended for support of the abdominal wall in the following situations.
External mechanical support of the abdominal wall in cases of reduced abdominal wall tone.
Support of the abdominal wall following surgery, on medical prescription.
Accompaniment of the recovery phase following abdominal surgery.
Limitation of abdominal pressures during everyday physical exertion.
Short-term, intermittent 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.
Mandatory precautions defined by the instructions for use
Never in a lying or semi-reclined position with the balloon inflated.
Never while driving a vehicle with the balloon inflated.
Never during intense physical exertion or abrupt movements.
Never directly on the skin — always over a thin garment.
Regular breaks to avoid prolonged compression.
The presence of ferromagnetic components makes wearing the device incompatible with MRI examination. The device must be removed before any MRI examination. This information must be given to the patient and recorded in the medical file.
Eligibility and contraindications
Prescription is intended for adult patients (18 years and over) for whom the intended purpose of the device, as defined by the instructions for use, corresponds to the clinical situation assessed by the physician. Assessment of patient eligibility falls strictly within the individual medical decision of the prescriber, who retains clinical independence of judgement at all times.
- Pregnancy
- Patients under 18 years of age
- Morbid obesity (BMI above 40 kg/m²)
- Irreducible or unsupported abdominal hernia
- Immediate post-operative phase 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
Possible undesirable effects
Transient abdominal discomfort, mild respiratory discomfort, skin redness or irritation in the area where the device is worn, gastric reflux in sensitive individuals. The device must be removed immediately in the event of pain, dyspnoea, nausea or dizziness.
Verifications to be carried out before prescribing
Patient aged 18 or over. Absence of the contraindications listed above. Absence of any condition that may be aggravated by abdominal compression. Patient informed that the device is not reimbursed. Patient informed of MRI incompatibility. Documenting these verifications in the patient file is good prescribing practice.
Reporting of undesirable events
A post-market surveillance system is in place in accordance with Article 83 of Regulation (EU) 2017/745. It is based on centralised collection of user feedback, systematic escalation of incidents, malfunctions and complaints to the legal manufacturer, periodic analysis under the post-market surveillance plan, and production of an annual report.
Conduct in the event of an undesirable event
Immediate removal of the device if still worn. Clinical assessment of the patient and referral according to severity. Documentation of the event — date, circumstances, duration of use, symptoms, context. Medical decision: adjustment of use, temporary suspension or definitive discontinuation. Reporting of any serious event, or event that may become serious, to the competent authority of the Member State in which the user or patient is established.
The lot number and product reference appear on the device label. The patient should be advised to keep the packaging and the instructions for use.
Legal manufacturer — GASTER Technology Limited, office@gastertechnology.com
Prescription, supply and available sizes
Reimbursement status
GASTER control® is not listed on the French list of reimbursable products and services (LPPR) and is not subject to any reimbursement by the statutory health insurance scheme. No listing application has been submitted. The cost of the device is specified to the patient at the point of supply.
Available sizes
| Size | Waist circumference | Balloon capacity | Max. pump strokes |
|---|---|---|---|
| Size 1 | 75 – 95 cm | 0.75 L | ~35 |
| Size 2 | 95 – 115 cm | 0.95 L | ~45 |
| Size 3 | 115 – 145 cm | 1.15 L | ~55 |
Maximum pump capacity is a technical safety specification, not a target for use. Adjustment must be guided by the patient's own perception — comfortable, perceptible, never painful. At size boundaries, the larger size should be preferred.
Supply channel
The device is supplied on medical prescription by orthotic specialists and pharmacists. Structured training materials are available for prescribers and for the professionals who supply and fit the device. A dedicated guide supports the first fitting of the patient.
Sample prescription wording
Allocation of responsibilities
Legal manufacturer. Conformity of the device with Regulation (EU) 2017/745, manufacturing quality (ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993), instructions for use, and post-market surveillance.
Distributor. Compliant distribution, product traceability, training of commercial teams and partner orthotic specialists, escalation of field information to the manufacturer, support to vigilance.
Prescriber. Individual clinical assessment, verification of eligibility criteria and absence of contraindications, patient information, written prescription, medical follow-up, reporting of undesirable events.
Orthotic specialist or pharmacist. Compliant supply, selection of the size matching the patient's waist circumference, morphological adjustment, demonstration of fitting and removal, patient information on cost and practical arrangements.
Patient. Use in accordance with the instructions for use, reporting of any discomfort or undesirable effect, adherence to the medical follow-up proposed.
Would you like more information?
Request the instructions for use, the training materials for prescribers and for the supply network, or discuss the practical arrangements for prescribing with our team.
Contact usGASTER control® — GASTER Technology Limited, 5/1 Merchants Street, Valletta VLT 1171, Malta. Proprietary biomechanical design (patent pending).