iMRS Prime – Class B Medical PEMF Device in Malaysia
The iMRS Prime is a next‑generation, multi‑modal bio-energetic system that combines low‑intensity pulsed electromagnetic fields (PEMF) with optional FIR, AVE and HRV technologies in a single, configurable platform suitable for clinical and integrative practice settings
iMRS Prime System overview
The iMRS Prime is the current flagship PEMF systems of Swiss Bionic Solutions and represents a full hardware and software redesign of the earlier iMRS/iMRS 2000 systems. Its architecture design centers on a 10.2″ multi‑core touch controller linked to a separate connector box that can connect up to six PEMF applicators plus Exagon Brain and Exagon Sense, with the ability to run two active independent sessions concurrently. The core mat and local applicators deliver low‑frequency, low‑intensity PEMF signals.
Software modes and clinical configuration
The Prime software platform offers a flexible and upgradeable environment for user operations. Several operational modes are relevant for clinical and professional use:
- Fast Start Programs: One‑touch, indication‑oriented protocols using organ‑clock logic and predefined intensity/time progressions, optionally combined with FIR and Exagon Brain.
- Program Mode: Allowing creation of virtually unlimited user and group profiles, each with its own applicator, intensity and duration settings.
- iGuide: An integrated database of over 250 preset profiles that provides suggested parameter sets (frequency structure via organ clocks, intensity, duration, applicator choice and time‑of‑day) for a wide range of conditions, intended to support non‑expert operators, including wellness centers operators in selecting safe, conservative starting protocols, especially for first time patients.
- Split Mode: A virtual “dual system” configuration enabled by the 10‑port connector box, where the controller runs two fully independent PEMF sessions (with separate applicators, Exagon Brain and Exagon Sense) in parallel.
Trial Mode is specifically aimed at health practitioners or clinicians who require full manual control of the parameters. Within Trial Mode, the operator can specify:
- Pulse Frequency
- Waveforms (sawtooth, rectangle/square, sine, triangle, trapezoid)
- Impulse width and breaks
- Magnetic field Intensity
- Session duration
- FIR mat temperature where applicable
These ranges allow construction of tightly controlled experimental protocols while staying within the manufacturer’s safety envelope. Because of power‑management limits, Hybrid (FIR) and Trial Mode are not combined with Split Mode in current firmware versions so as to avoid overloading the system.
For professional users, Swiss Bionic and regional distributors provide modality‑specific education (PEMF, FIR, HRV, brainwave entrainment) through the iMRS Prime Academy, along with system‑specific training and certification for advanced configurations. This training, together with the built‑in iGuide database and conservative default parameter ranges, is designed to support safe integration of the iMRS Prime into multidisciplinary, complementary and preventive care settings
Regulatory status in Malaysia
- Medical Device Class: Class B, General Medical Device, System.
- Malaysian Registration No. (MDA): GB7916925‑214856.
- Legal framework: Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012.
Certified indications (applicable for Malaysia)
The iMRS Prime System (including Exagon applicators and accessories registered under GB7916925‑214856) is registered in Malaysia for use in the following therapeutic purposes:
- Promotion of bone healing, for example in cases of bone fractures.
- Reduction of pain sensation.
- Improvement of wound healing in soft tissue and skin.
- Improvement of peripheral micro‑circulation.
Intended Users and Setting
The iMRS Prime is intended for use by healthcare professionals and trained lay users, in:
- Hospital and clinic environments (supervised application)
- Professional therapy and rehabilitation practices
- Home settings, when installed and used according to the instructions for use
Contraindications and precautions (summary)
Do not use:
- During pregnancy
- In individuals with epilepsy
- In individuals with electronic implants such as pacemakers or insulin pumps, unless explicitly approved and supervised by a relevant specialist
- In individuals undergoing immune-suppression medication
- In children younger than 2 weeks of age
Use only under medical advice and appropriate supervision in cases of:
- Active growing Tumour diseases
- Serious cardiac arrhythmias
- Acute episodes of hyperthyroidism
- Known hypersensitivity to electromagnetic fields
The full list of warnings, precautions and potential adverse effects is provided in the official Instructions for Use (IFU) supplied with each system.
Authorized Representative for Malaysia
Global Rep Sdn. Bhd.
Authorized Representative for Swiss Bionic Solutions Schweiz GmbH in Malaysia.
Address: 88‑2‑36, Kompleks Sri Wonder, 10150 Jelutong, Pulau Pinang, Malaysia.
Certificate holder for the Malaysian registration GB7916925‑214856.
Manufacturer (Legal Manufacturer)
Swiss Bionic Solutions Schweiz GmbH
Schulhausstrasse 17, CH‑8834 Schindellegi, Switzerland.
ASEAN office contact: email: sg@swissbionic.com | WhatsApp, Mobile: (65) 8757-5323