At Hyperstate Recovery, we believe in transparency and informed choice. Our mission is to empower you with accurate information so you can use your recovery equipment safely, effectively, and confidently.
1. What Does FDA Approval Mean?
The U.S. Food & Drug Administration (FDA) regulates medical devices to protect public health. A product is FDA-approved or cleared when the FDA determines that the benefits outweigh potential risks, based on extensive review of clinical data, lab testing, and manufacturing practices.
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FDA-Cleared devices have been formally reviewed and authorized for specific medical uses.
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FDA-Registered devices have been registered with the FDA, meaning the manufacturer has disclosed the device’s existence — but this does not imply approval or clearance for any specific medical claim.
2. Product Classification: What You’re Buying
Our catalog includes both FDA-cleared Class II medical devices and FDA-registered wellness technologies.
For example:
✅ OxyRevo and MACY-PAN hyperbaric chambers are:
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Class II medical devices under 21 CFR 868.5470
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FDA-cleared for specific medical indications
As of October 2021, the FDA has cleared HBOT for 14 approved conditions, including:
- Decompression Sickness
- Air or Gas Embolism
- Carbon Monoxide Poisoning
- Gas Gangrene
- Severe Anemia
- Intracranial Abscess
- Crush Injuries
- Compartment Syndrome
- Radiation Tissue Damage
- Central Retinal Artery Occlusion
- Thermal Burns
- Sudden Hearing Loss
- Skin Graft Complications
- Osteomyelitis (Refractory)
For these cleared uses, a prescription is legally required in the United States.
3. Understanding Off-Label Use
Many customers choose HBOT for conditions not yet FDA-cleared, including:
- Traumatic Brain Injury (TBI)
- PTSD
- Lyme Disease
- Fibromyalgia
- Chronic Fatigue
- Alzheimer’s Disease
- Autism
- CRPS (Complex Regional Pain Syndrome)
- Athletic Recovery & Performance
- Fatigue
- Inflammation
- General Wellness
This is known as off-label use — and it’s more common than you may realize:
- ⚠️ Off-label use means the product is being used for a purpose not officially cleared by the FDA.
- ✅ It is legal and widely accepted in medicine when guided by a qualified healthcare professional.
Off-label use is not unique to HBOT — medications (like antidepressants or seizure meds) are prescribed off-label for pain, migraines, or neurological disorders.
Physicians often prescribe HBOT off-label when supported by emerging clinical evidence, international standards, and patient experience.
Legal Disclaimer: The FDA has not formally evaluated off-label uses and we recommend speaking with your healthcare provider before starting HBOT.
4. Prescription Policy
Home Use: A valid prescription is required for FDA-cleared indications. However, you may place your order now and submit your prescription within 30 days (send to sales@hyperstaterecovery.com). We’ll reserve your unit and ship as soon as documentation is received.
Need help? After purchase, we can connect you with a licensed telehealth provider for $50 to obtain a valid prescription.
Facility Use: If you’re ordering for a licensed medical facility (hospital, clinic, etc.), a prescription is not required.
5. No Medical Claims
Unless explicitly stated for FDA-cleared products:
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The FDA has not evaluated the products or claims on hyperstaterecovery.com.
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Our equipment is not intended to diagnose, treat, cure, or prevent any disease.
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All website content is for educational purposes only and not a substitute for medical advice.
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Hyperstate Recovery complies with all FDA marketing guidelines and does not make claims that HBOT can cure unapproved conditions.
- Hyperstate Recovery is not liable for misuse or adverse outcomes.
6. Product Safety & Customer Responsibility
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All products ship brand new and unopened directly from the manufacturer.
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Setup, maintenance, and safe operation are the responsibility of the end user.
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Hyperstate Recovery is not liable for injuries, adverse effects, or misuse.
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Please carefully follow all user manuals and safety guidelines.
7. Questions?
We’re here to help with any questions about:
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FDA classification
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Off-label use
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Prescription requirements
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Medical supervision
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How to safely use your equipment
📧 Email: sales@hyperstaterecovery.com
📱 Call or Text: (888) 594-8988
