Newtowne 54" Tent Hyperbaric Chamber-Sit or Recline

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Hyperbaric Chamber Class 2 Medical Device Disclaimer

Hyperbaric Chamber Class 2 Medical Device Disclaimer

Class II Devices

The FDA categorizes Class II medical devices as those with moderate to high risk to the patient or user, and the majority of medical devices fall into this category.

Perscription Required

Hyperbaric chambers cannot be sold or used without the prescription of a licensed physician. A prescription for this unit must be submitted within 30 days of purchase.

FDA Approval

The FDA has approved hyperbaric oxygen therapy (HBOT) for specific medical conditions, and marketing a hyperbaric chamber for any indication not listed and not cleared through the 510(K) clearance process is considered off-label and illegal.

Examples of FDA-Approved Conditions

Some of the conditions for which HBOT is FDA-approved include: carbon monoxide poisoning, gangrene, and wounds that won't heal.

Types of Hyperbaric Chambers

There are two main types of hyperbaric chambers: medical grade and non-medical grade. Medical grade chambers are FDA-approved and can reach pressures of 3.0 ATA, while non-medical grade chambers are not FDA-approved and are not covered by insurance.

NFPA Standards

The National Fire Protection Association (NFPA) has standards for hyperbaric facilities and the chambers within, which are found in Chapter 14 of NFPA 99, Health Care Facilities Code.

Class A and Class B chambers

Hyperbaric chambers can be classified as Class A (multiple occupants) or Class B (single occupant).

Disclaimer: By placing your order, you must agree to the statement below:

My physician has prescribed this product for my medical condition. I will read and carefully follow the manufacturer's directions provided with the product. I assume all responsibility for the use/misuse of this Hyperbaric Chamber. I will contact my physician immediately in the case of any untoward reactions caused by use of this product. By clicking "Add to Cart" you certify your acceptance of the above statement.

*A prescription for this unit must be submitted within 30 days of purchase.*

 

Features

 

Optimize your healing in a 1.3 ATA USA-made hyperbaric chamber that combines the latest in safety with ample space for therapeutic comfort. The Newtowne Tent Hyperbaric Chamber is a spacious, vertical-style, FDA-cleared chamber designed for two people or extra-spacious treatment for one person. It comes with a camp mat and a chair and allows for the addition of a personal zero-gravity lounge chair for extra comfort.

This chamber is 72 inches long, 40 inches wide at the center, and 58 inches tall, providing sufficient space to comfortably sit or lie down. It can accommodate up to two people, making it versatile for individual or shared use in both home and clinical settings. The innovative upright zipper entrance makes it a great choice for patients who have difficulty getting in and out of a traditional lie-down style hyperbaric chamber. With the Newtowne tent, two people can sit up, lie down, or share a bean bag inside the chamber. The versatility of this chamber makes it a great option for clinics that want to offer a two-person chamber that can accommodate different preferences.

Newtowne Hyperbarics has been a leading provider of mild hyperbaric chambers for over 20 years. Our products are all made in the USA and are designed with a focus on safety. Each chamber comes with a two-year warranty, extendable to five years.


  • FDA Clearance for Assured Safety: This chamber meets stringent safety standards, ensuring a secure environment for users.
  • Spacious Interior: The chamber measures 72 inches in length, 40 inches in width, and 58 inches in height, offering ample space for comfortable movement and positioning.
  • Dual Occupancy: Accommodates two people simultaneously, allowing for shared sessions that are efficient and beneficial for couples or patient assistance.
  • Customizable Comfort: Includes a basic camp mat and a chair, with the option to add your own zero-gravity lounge chair for enhanced relaxation during use.
  • Vertical Style Design: Its vertical configuration allows users to either sit up or lie down, providing flexibility depending on therapeutic needs and personal comfort preferences.
  • Bright, Clean Aesthetics: The chamber features a bright white exterior and interior, promoting a clean and professional look while enhancing visibility and a sense of openness.
  • American Made: Proudly designed and manufactured in the USA, ensuring high-quality craftsmanship and adherence to safety standards.
  • Extended Warranty Options: Comes with a two-year warranty, with the possibility to extend up to five years, offering long-term security and support.
  • Proven Safety Record: Maintains a 100% safety record since its inception in 2001, reflecting Newtowne Hyperbarics' commitment to user security.
  • Versatile for All Settings: Equally suitable for use in medical facilities and home settings, providing flexibility for all types of users and therapeutic scenarios.

 

Specifications:

 

  • Type: Vertical Style Hyperbaric Chamber

  • Length: 72 inches

  • Width: 40 inches (center of chamber)

  • Height: 58 inches

  • Interior Height: 54 inches

  • Capacity: Fits up to two people

  • Included Accessories: Camp mat and a chair

  • Additional Compatibility: Can accommodate a personal zero-gravity lounge chair

  • Material: High-grade materials for durability and safety

  • Color: Bright white interior and exterior

  • Manufacturing Location: USA

  • Safety Record: 100% safety record since 2001

  • Warranty: Standard two-year warranty, extendable to five years

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