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Interpretation Response #11-0072 ([AirSep Corporation] [Mr. Richard W. Boerdner])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: AirSep Corporation

Individual Name: Mr. Richard W. Boerdner

Location State: NY Country: US

View the Interpretation Document

Response text:

April 20, 2011


Mr. Richard W. Boerdner
Production Manager
AirSep Corporation
401 Creekside Drive
Buffalo, NY 14228-2085

Reference No. 11-0072

Dear Mr. Boerdner:

This responds to your March 25, 2011 letter and subsequent telephone conversation with a member of my staff regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator (POC) for purposes of obtaining FAA approval to allow a passenger to carry the POC aboard an aircraft. According to your letter, the POC (trade name Focus) is a device that separates oxygen from ambient air through a process called Pressure Swing Absorption (PSA). The device uses oxygen conserving technology to provide supplemental oxygen to persons with medical needs. The maximum operating pressure of the POC is 39 psia at 20 °C. The POC is powered by multiple sources, including AC or DC power, and a rechargeable lithium-ion battery pack. The battery pack consists of four 2.6 Ah lithium-ion cells equating to an equivalent lithium content of 0.78 g per cell and 3.12 g aggregate equivalent lithium content for the battery pack (38.48 Wh). The lithium-ion battery pack is a type proven to meet the appropriate tests in the United Nations Manual of Tests and Criteria, and the battery pack is packaged in a manner to prevent short circuits when offered for transport or carried onboard passenger aircraft. You ask whether this device is regulated under the HMR.

Based on the information provided in your letter, the Focus POC is currently not subject to the HMR because: (1) the pressure of the oxygen in the device does not exceed 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F); (2) the lithium-ion battery pack used to operate the device is excepted from the HMR under § 172.102(c)(1), Special provision 188; (3) the POC contains no other materials subject to the HMR; and (4) the battery pack is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (e.g., by the effective insulation of exposed terminals).

Although the exception in § 175.10(a)(18) of the HMR would apply to a passenger carrying a Focus POC as described above, approval by the Federal Aviation Administration (FAA) is required before it may be used by a passenger onboard an aircraft. The FAA published a final rule on July 12, 2005 (70 FR 40155) regarding these devices. For further assistance, you may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch (AFS-220) by phone at (202)-267-3732 or email at In addition, even with FAA approval, an air carrier ultimately determines what may or may not be carried on its aircraft. We suggest that you contact the airlines to ensure that the Focus POC may be carried.

I trust this satisfies your inquiry. Please contact us if we can be of further assistance.


Ben Supko
Acting Chief, Standards Development Branch
Standards and Rulemaking Division

172.102 SP 188, 175.10(a)(10)

Regulation Sections

Section Subject
173.185 Lithium cells and batteries
175.10 Exceptions for passengers, crewmembers, and air operators