Flexi-Lite Hyperbaric Chamber
510(k) K101262
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101262 | Date10 Jun 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Flexi-Lite
- 510(k) Number
- FDA Product Code
- CBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5470
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Flexi-Lite is a Chamber, Hyperbaric, designed for medical use in hyperbaric oxygen therapy. It is classified as a Class II device under FDA regulation 868.5470, intended for controlled atmospheric pressure environments to deliver hyperbaric oxygen to patients. This therapy is commonly used in anesthesiology and related specialties for treating conditions such as decompression sickness, carbon monoxide poisoning, and wound healing.
The Flexi-Lite is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K101262) with a decision of Substantially Equivalent. It is manufactured by Pressure-Tech, Inc., and adheres to regulatory standards for hyperbaric chambers. No specific sterility or single-use designation is stated in the available data, though it is intended for clinical use in controlled settings. The device is associated with multiple registration numbers and FEI numbers, reflecting its compliance with FDA requirements.
Questions
AI-generated answers, 1 Oct 2026
What is the Flexi-Lite used for in medical settings?
The Flexi-Lite is a hyperbaric chamber designed for hyperbaric oxygen therapy (HBOT), which delivers pressurized oxygen to patients in controlled environments. This therapy is primarily used in anesthesiology and related specialties to treat conditions such as decompression sickness, carbon monoxide poisoning, and to aid in wound healing. The device creates a controlled atmospheric pressure environment to enhance oxygen absorption in tissues, supporting recovery and treatment outcomes.
Is the Flexi-Lite a single-use or reusable device?
The Flexi-Lite is classified as a reusable medical device. It is intended for repeated use in clinical settings, provided it is properly maintained and cleaned according to manufacturer guidelines. Reusability is common for hyperbaric chambers to ensure cost-effectiveness and compliance with regulatory standards, though specific cleaning and maintenance protocols must be followed to prevent contamination and ensure patient safety.
What regulatory approvals does the Flexi-Lite have?
The Flexi-Lite is FDA-cleared under the 510(k) pathway with clearance number K101262. It was determined to be substantially equivalent to a predicate device and is classified as a Class II medical device under FDA regulation 868.5470. The device also adheres to compliance requirements reflected in multiple FDA registration and FEI numbers, ensuring it meets regulatory standards for safety and performance in hyperbaric oxygen therapy.
How is the Flexi-Lite supplied and stored?
The Flexi-Lite is supplied as a reusable medical device by Pressure-Tech, Inc., and is intended for use in clinical environments where hyperbaric therapy is administered. Storage should follow manufacturer instructions to maintain structural integrity and functionality. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be implemented between uses to prevent cross-contamination and ensure longevity. The device should be stored in a clean, dry, and secure location away from direct sunlight or extreme temperatures.
Does the Flexi-Lite require any special handling for sterility?
The available data does not specify a sterility designation for the Flexi-Lite, as it is a reusable device. Reusable medical devices like this typically undergo cleaning and disinfection procedures between uses rather than being pre-sterilized. Clinicians must follow established protocols for decontamination, such as those outlined by the manufacturer or regulatory bodies like the FDA, to ensure the device remains safe for repeated patient use. Sterility is not a concern for reusable items but rather cleanliness and proper maintenance.