MIHA BODYTEC
Report
- Report Number
- 3015529344-2025-00002
- Event Type
- Injury
- Date Received
- December 19, 2025
- Date of Event
- May 15, 2025
- Report Date
- December 19, 2025
- Manufacturer
- MIHA BODYTEC GMBH
- Product Code
- IPF
- UDI-DI
- 04260646650014
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NE, US
- Reporter Occupation
- 505
Narratives
WE HEREBY PROVIDE THE RELEVANT MEDICAL, SCIENTIFIC, AND PROCEDURAL CONTEXT REGARDING THE REPORTED INCIDENT IN WHICH A CUSTOMER WAS HOSPITALIZED WITH SUSPECTED EXERTIONAL RHABDOMYOLYSIS AFTER RECEIVING A 20-MINUTE FIRST-TIME WHOLE-BODY ELECTROMYOSTIMULATION TRAINING SESSION CONDUCTED BY A TRAINER. THIS INFORMATION IS INTENDED TO SUPPORT YOUR ASSESSMENT. WHOLE-BODY ELECTROMYOSTIMULATION (WB-EMS) IS A SUPERVISED TRAINING METHOD THAT USES LOW-FREQUENCY ELECTRICAL IMPULSES TO SIMULTANEOUSLY ACTIVATE MULTIPLE LARGE MUSCLE GROUPS THROUGH A SPECIALIZED SUIT OR VEST EQUIPPED WITH ELECTRODES. WB-EMS IS THEREFORE A TRAINING MODALITY, NOT A PASSIVE MEDICAL TREATMENT, AND MUST BE APPLIED WITH PROGRESSIVE LOADING, ESPECIALLY FOR FIRST-TIME USERS. 1. EXERTIONAL RHABDOMYOLYSIS: TRAINING-LOAD CONDITION, NOT DEVICE MALFUNCTION. EXERTIONAL RHABDOMYOLYSIS ("E-RHABDO") IS A WELL-CHARACTERIZED PHYSIOLOGICAL RESPONSE TO EXCESSIVE MUSCULAR OVERLOAD, ESPECIALLY IN UNACCUSTOMED INDIVIDUALS. IT IS WIDELY DOCUMENTED ACROSS TRADITIONAL TRAINING CONTEXTS SUCH AS: MILITARY BASIC TRAINING. HIIT AND CROSSFIT. MARATHON PREPARATION. ECCENTRIC STRENGTH PROGRAMS. THERE IS NO EVIDENCE IN SPORTS MEDICINE THAT A PROPERLY FUNCTIONING WB-EMS DEVICE CAN CAUSE RHABDOMYOLYSIS. E-RHABDO IS EXCLUSIVELY RELATED TO MISAPPLIED TRAINING LOAD, NOT DEVICE DEFECTS. 2. INTERNATIONALLY RECOGNIZED SAFETY STANDARD (FRONTIERS IN PHYSIOLOGY, 2023). THE CURRENT GLOBAL STANDARD OF CARE FOR WB-EMS SAFETY IS DEFINED IN THE PEER-REVIEWED PUBLICATION: "POSITION STATEMENT AND UPDATED INTERNATIONAL GUIDELINE FOR SAFE AND EFFECTIVE WHOLE-BODY ELECTROMYOSTIMULATION TRAINING," FRONTIERS IN PHYSIOLOGY (2023). THIS GUIDELINE WAS CREATED BY AN INDEPENDENT PANEL OF INTERNATIONAL MEDICAL EXPERTS. ONE OF THE AUTHORS IS A PHYSICIAN FROM THE MAYO CLINIC (USA) - CONSISTENTLY RANKED AMONG THE BEST HOSPITALS IN THE UNITED STATES. THIS CONFIRMS THAT THE GUIDELINE REPRESENTS: AN EVIDENCE-BASED, CLINICALLY VALIDATED, AND INTERNATIONALLY ACCEPTED STANDARD OF CARE FOR WB-EMS. FOR CLARITY, TRANSPARENCY, AND EASE OF REVIEW, WE HAVE ATTACHED THE ORIGINAL TEXT OF THE GUIDELINE, WITH ALL RELEVANT PASSAGES CONCERNING FIRST-SESSION LOAD LIMITS AND EXERTIONAL RHABDOMYOLYSIS CLEARLY HIGHLIGHTED. 3. MANDATORY REDUCED VOLUME AND REDUCED INTENSITY FOR FIRST-TIME WB-EMS SESSIONS. THE INTERNATIONAL GUIDELINE PROVIDES A CLEAR, SPECIFIC, AND CONSERVATIVE PROTOCOL FOR FIRST-TIME WB-EMS USERS TO MINIMIZE METABOLIC OVERLOAD AND REDUCE THE RISK OF EXERTIONAL RHABDOMYOLYSIS. THE REQUIRED PRECAUTIONS CONCERN BOTH TRAINING DURATION AND IMPULSE INTENSITY. (A) REDUCED TRAINING VOLUME THE GUIDELINE STRICTLY LIMITS FIRST-SESSION EXPOSURE TO: 5 MINUTES OF IMPULSE FAMILIARIZATION (CONTINUOUS PROTOCOL; NON-TRAINING LOAD). 12 MINUTES OF INTERMITTENT WB-EMS (SHORT 4-SECOND PULSES WITH 4-SECOND BREAKS). GUIDELINE EXCERPT: "THE FIRST WB-EMS SESSION SHOULD BE CONDUCTED WITH A REDUCED VOLUME.. WE ADVISE (1) 5 MIN IMPULSE FAMILIARIZATION AND (2) 12 MIN OF INTERMITTENT WB-EMS WITH SHORT STIMULATION PHASES AND SHORT BREAKS." THIS RESULTS IN A MAXIMUM OF 12 MINUTES TRAINING-RELEVANT EMS LOAD FOR FIRST-TIME USERS. (B) REDUCED IMPULSE INTENSITY (A SECOND MANDATORY SAFETY REQUIREMENT). IN ADDITION TO LIMITING DURATION, THE GUIDELINE MANDATES REDUCED STIMULATION INTENSITY DURING THE FIRST WB-EMS SESSION: LOW-TO-MODERATE INITIAL INTENSITY LEVELS. NO HIGH-INTENSITY CONTRACTIONS IN THE FIRST SESSION. STRICT SUPERVISION AND CONTINUOUS COMMUNICATION WITH THE USER. THIS INTENSITY REDUCTION IS EXPLICITLY INTENDED TO PROTECT UNACCUSTOMED USERS FROM METABOLIC OVERLOAD AND RHABDOMYOLYSIS RISK. SUMMARY OF DUAL SAFETY REQUIREMENTS. FOR FIRST-TIME WB-EMS USERS, THE GUIDELINE REQUIRES: 1. REDUCED VOLUME: MAXIMUM 12 MINUTES OF INTERMITTENT WB-EMS. 2. REDUCED INTENSITY: LOW-TO-MODERATE IMPULSE LEVELS WITH SLOW PROGRESSIVE RAMPING. BOTH REQUIREMENTS WERE ESTABLISHED TO MINIMIZE RISK IN UNACCUSTOMED USERS. A 20-MINUTE TRAINING SESSION AT FULL TRAINING INTENSITY THEREFORE CONTRADICTS BOTH CORE SAFETY PROVISIONS OF THE INTERNATIONALLY ACCEPTED GUIDELINE. 4. MIHA BODYTEC: FULL COMPLIANCE WITH DUTY OF CARE. MIHA BODYTEC: INTEGRATES ALL GUIDELINE REQUIREMENTS INTO ITS OPERATING MANUAL, PROVIDES MANDATORY AND STANDARDIZED TRAINER EDUCATION, REQUIRES TRAINERS TO FORMALLY CONFIRM UNDERSTANDING OF SAFETY PROTOCOLS, INSTRUCTS TRAINERS EXPLICITLY ON THE REDUCED INITIAL EXPOSURE REQUIRED FOR NEW USERS. IN THE PRESENT CASE, THE TRAINER: COMPLETED AND ACKNOWLEDGED THE REQUIRED TRAINING, HAD FULL KNOWLEDGE OF THE GUIDELINE-BASED PROTOCOL, BUT DID NOT FOLLOW THE REQUIRED REDUCED EXPOSURE PARAMETERS. THUS, THE DEVIATION OCCURRED AT THE APPLICATION LEVEL NOT AT THE MANUFACTURER OR DEVICE LEVEL. 5. LIABILITY ASSESSMENT - BASED ON: ESTABLISHED SPORTS MEDICINE PRINCIPLES, THE 2023 INTERNATIONAL GUIDELINE CO-AUTHORED BY THE MAYO CLINIC, THE MANUFACTURER'S DOCUMENTED SAFETY INSTRUCTIONS, THE STANDARDIZED TRAINING PROVIDED TO THE TRAINER, AND THE CLEAR OVERLOAD BEYOND THE RECOMMENDED 12-MINUTE FIRST-SESSION LIMIT. THE INCIDENT IS CONSISTENT WITH TRAINER-INDUCED OVEREXERTION OF AN UNACCUSTOMED FIRST-TIME USER. THERE IS NO INDICATION OF A DEVICE MALFUNCTION OR PRODUCT DEFECT. THE FULL TEXT OF THE CITED GUIDELINE (FRONTIERS IN PHYSIOLOGY, 2023) IS PROVIDED FOR REVIEW. THIS IMPORTER REPORT REFERENCES THE MANUFACTURER'S MDR (MFR REPORT #: 3010385841-2025-00002) REGARDING THIS EVENT. THE MANUFACTURER CONDUCTED THE INVESTIGATION AND PROVIDED ALL RELEVANT FINDINGS.
FIRST-TIME USER EXPERIENCED SEVERED RHABDOMYOLYSIS FOLLOWING AN INITIAL WHOLE-BODY EMS TRAINING SESSION AND WAS HOSPITALIZED FOR APPROXIMATELY FIVE DAYS. THE SESSION WAS CONDUCTED USING A MIHA BODYTEC M.OVE DEVICE IN COMBINATION WITH THE I-BODY CONNECT WIRELESS UNIT AT A CUSTOMER LOCATION. THE USER'S FIRST EMS SESSION LASTED APPROXIMATELY 20 MINUTES OF INTERMITTENT STIMULATION, EXCEEDING THE STANDARD INITIAL SESSION DURATION RECOMMENDED IN THE DEVICE'S INSTRUCTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255930 | MIHA BODYTEC | MIHA BODYTEC M.OVE | IPF | MIHA BODYTEC GMBH | 04260646650014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Hospitalization |