Balanced Body Inc

Balanced Body Inc specializes in Pilates-specific exercise equipment, which includes reformers with trapeze attachments, various footbar configurations (like steel or adjustable footbars), and mat conversion towers. Their portfolio also covers Cadillac frames—used for Pilates training—and accessory toy boxes. These devices are designed for controlled resistance and mobility exercises, primarily in clinical, rehabilitative, or fitness settings where Pilates is applied.

Balanced Body Inc is headquartered in the United States. While the company’s headquarters are in the US, its Pilates equipment is marketed globally, serving clients in clinical, rehabilitation, and fitness environments worldwide. The regulatory classification and listing (e.g., in euDAMED) reflect its international presence, particularly in the European market.

Balanced Body Inc’s devices are listed in the euDAMED registry, which is the European Union’s database for medical devices. This listing is required for Class I devices marketed in the EU, ensuring transparency about the manufacturer and device details. Since all listed devices fall under Class I classification, they undergo minimal regulatory scrutiny but still require compliance with EU Medical Device Regulations (MDR) or previous directives.

All devices produced by Balanced Body Inc are classified as Class I under EU regulations. This classification applies to low-risk medical devices, such as Pilates equipment, which are intended for general wellness, exercise, or rehabilitation without invasive procedures. Class I devices typically require basic conformity assessments and mandatory listing in euDAMED, but they do not undergo rigorous pre-market clinical trials.