Bioinfinity (M) Sdn. Bhd.

Bioinfinity (M) Sdn. Bhd. specializes in perineometer devices, which are tools used to evaluate and strengthen pelvic floor muscles. Their primary product line includes devices like the Vibrance® Pelvic Trainer and the VIBRANCE KEGEL DEVICE (VKD), designed for clinical and rehabilitation use in physical therapy.

Bioinfinity (M) Sdn. Bhd. is based in the United States. Their devices fall under Class II classification in the US regulatory framework, which applies to moderate-risk medical products requiring special controls to ensure safety and effectiveness.

Yes, Bioinfinity’s devices are included in the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. The 510(k) process ensures that devices meet FDA requirements for safety and performance by demonstrating substantial equivalence to a legally marketed predicate device. The UDI system helps track and trace devices throughout their lifecycle.

Bioinfinity’s perineometer devices, such as the Vibrance® Pelvic Trainer, are used to assess and rehabilitate pelvic floor muscle function. These tools are commonly utilized by physical therapists, pelvic floor specialists, and rehabilitation professionals to aid patients recovering from childbirth, surgery, or conditions like incontinence or pelvic floor dysfunction.