What XBody is
XBody, from Hungary, sells EMS systems to studios, physiotherapists and personal trainers under the names Pro USA, Go USA and Newave USA. The FDA database lists three clearances: K190038 from 2019, K221200 from 2023 and K242926 from May 2025.[2]
Technology
The K221200 summary describes “6 output channels, but 12 independently regulated outputs”, a frequency range of 1 to 150 Hz and pulse widths of 50 to 500 microseconds, controlled from a tablet. It requires a “qualified and trained operator”, and describes cotton underwear that is watered with tap water before the session.[1]
A note on wording
XBody’s US site describes its devices as “FDA Approved”. A 510(k) is a clearance, not an approval. The difference matters, and we explain it in the FDA guide.
Who should buy it
Studio owners comparing professional systems. Ask for a full quote including suits, service and training, and compare it with miha bodytec, E-Fit and VisionBody Pro.
How XBody scores
- Stimulation technology, 7.5: Twelve independently regulated outputs and the widest pulse-width range here. Points lost for wet preparation in the US filing. A dry-suit option is advertised, but we could not verify its details.
- Control and software, 8.0: Tablet-based control designed for trainers, not for self-guided use.
- Comfort, hygiene and care, 5.0: Undergarments are wetted before training according to the US filing.
- Safety and certification, 7.5: Three FDA 510(k) clearances between 2019 and 2025 and mandatory trained operation. Its US site uses the term “FDA Approved”, which is not the correct term for a 510(k) clearance.
- Cost and ownership, 4.5: No public pricing. Established international distribution.
What we like
- Three FDA 510(k) clearances, the latest from May 2025
- 12 independently regulated outputs
- Wide parameter range: 1–150 Hz, 50–500 µs
What to weigh up
- Professional system, trained operator required
- No public pricing
- US site says “FDA Approved”, which overstates a 510(k) clearance
- Several details could not be verified because the manufacturer site blocked automated access
XBody specifications
| Built for | Studios, physiotherapists, trainers[1] |
|---|---|
| Cables | Cabled and wireless models[1] |
| Electrodes | US filing: cotton underwear “watered using normal tap water”[1] |
| Channels / muscle groups | “6 output channels, but 12 independently regulated outputs”[1] |
| Frequency range | 1–150 Hz[1] |
| Pulse width | 50–500 µs[1] |
| Control | Tablet[1] |
| Battery | not published |
| Suit care | not published |
| Certification | FDA 510(k) K190038, K221200, K242926. Prescription use with a trained operator[2] |
| Price | not published |
| Ongoing fees | Not applicable |
| Warranty | not published |
Verdict
XBody is a credible alternative to miha bodytec for studios. Like miha, it is not something you buy for your living room.
Sources
- FDA 510(k) summary K221200, XBody Go USA and Pro USA – www.accessdata.fda.gov/cdrh_docs/pdf22/K221200.pdf (accessed 20 Sep 2026)
- FDA 510(k) database entry K242926 – www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242926 (accessed 20 Sep 2026)