The fastest way to get in trouble with a recovery wing is to over-claim. Here's the line — per modality — so your marketing stays clean and your members stay safe.
Class I vs Class IIa — what it means for your copy
Medical-device class sets how far your claims can go. In the Pragma catalogue, e°CABIN, X°CRYO, LedPro and X-TONE are Class I (wellbeing / recovery language). OxyPro is Class IIa — the tightest, and the one to watch.
The three hard lines
- No whole-body cryo device is FDA-cleared, and there's no evidence it treats disease. Recovery/wellbeing language only.
- Hyperbaric is the danger zone. The European hyperbaric bodies (ECHM & EUBS) explicitly advise against promoting mild hyperbaric therapy for “wellness”, “energy” or unproven disease claims. OxyPro copy must be the most conservative of the five — factual, supervised, no efficacy promises.
- HIEMT: cite averages, not guarantees. The body-contouring evidence is strong, but it's study averages — never a personal promise.
Safe-claim cheat sheet
| Cabin | Class | You can say | Don't say |
|---|---|---|---|
| e°CABIN / X°CRYO | I | Recovery, wellbeing, short-term relief | Cures, treats disease, FDA-approved |
| LedPro | I | Recovery, circulation, skin, wellbeing | Medical skin/disease treatment |
| X-TONE | I | Muscle toning, strength (avg results) | Guaranteed fat loss / medical claims |
| OxyPro | IIa | Factual description, supervised sessions | Wellness/energy/disease claims (ECHM/EUBS) |
One process that covers you
Screen contraindications at intake for every modality (cardiovascular, implants, pregnancy, cold sensitivity), keep OxyPro supervised, and keep a claims register so marketing can't drift past the class. The catalogue already feeds a /compliance/ claims register for exactly this.
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