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Operator Insight · Compliance

MDR compliance: what you can and can't claim

The fastest way to get in trouble with a recovery wing is to over-claim. The line — per modality — so your marketing stays clean and your members stay safe.

Pragma Recovery Technologies · operator briefing · 2 August 2026 · not medical advice
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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

Safe-claim cheat sheet

CabinClassYou can sayDon't say
e°CABIN / X°CRYOIRecovery, wellbeing, short-term reliefCures, treats disease, FDA-approved
LedProIRecovery, circulation, skin, wellbeingMedical skin/disease treatment
X-TONEIMuscle toning, strength (avg results)Guaranteed fat loss / medical claims
OxyProIIaFactual description, supervised sessionsWellness/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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