| K-number | K243488 |
| Device name | VMAT PRO |
| Applicant | Termosalud |
| Product code | ISA |
| Device class | Class I |
| Decision date | Feb 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5660 |
The VMAT PRO is a therapeutic massage device that uses pneumatically generated pressure pulses delivered through interchangeable handpiece transmitters to treat minor muscle aches and pains, increase local blood circulation, and activate connective tissue. It operates continuously at variable frequencies (1-21 Hz) with adjustable pressure settings (0.5-5.0 bar) and includes four transmitter heads of different sizes for ergonomic treatment of various body areas.
The VMAT PRO uses pneumatic/ballistic pressure wave generation identical to the predicate D-Actor 200, with the same pulse repeat rate (1-21 Hz), similar driving power (1-5 bar), comparable projectile mass (3.1g vs 3g), and nearly identical derived pulse-intensity integral values that demonstrate energy concentration. Minor differences exist in maximum pressure range (0.5-5.0 bar vs 1-5 bar) and applicator head displacement measurements, but these are attributable to different measurement methodologies rather than functional design differences.
IEC 60601-1:2005 (Third Edition) + A1:2012 for medical electrical equipment safety and performance, IEC 60601-1-2:2014 for electromagnetic compatibility, IEC 63045:2020 for pressure pulse source characteristics, ISO 10993-1:2018 for biocompatibility of tissue-contacting materials, and FDA guidance on software verification and validation.
The VMAT PRO is substantially equivalent because it has identical indications for use and similar overall pneumatic/ballistic design as the predicate D-Actor 200. The critical efficacy parameter—derived pulse-intensity integral (energy flux density)—is nearly identical between devices at comparable pressure settings. Measurement value differences stem from the VMAT PRO using the newer IEC 63045 standard versus the predicate's modified IEC 61846 protocols, not from functional differences. All operational parameters including frequency range, pulse characteristics, and energy concentration are within standard ranges for pressure pulse devices, confirming equivalent safety and efficacy.
View the full FDA submission: accessdata.fda.gov