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Interpretation Response #12-0199 ([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:

September 20, 2012

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

Ref. No. 12-0199

Dear Mr. Boerdner:

This responds to your September 5, 2012 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a portable oxygen concentrator your company manufactures and is known by the trade name FreeStyle 5. You ask whether this device is regulated as a hazardous material under the HMR.

You state the FreeStyle 5 is a device that separates oxygen from ambient air through a process called Pressure Swing Absorption (PSA). The maximum operating pressure of the oxygen exerted within the device is less than 200 kPa (gauge) at 20 °C. The device can be powered by multiple power sources, including AC or DC power and a rechargeable 4.8 Ah, 71.04 Wh, lithium ion battery pack. The lithium ion cells and battery pack have been tested pursuant to Sub-section 38.3 of the United Nations Manual of Tests and Criteria and are packaged in a manner to prevent short circuits when offered for transportation or are carried onboard passenger-carrying aircraft.

Based on the information provided, the oxygen in the FreeStyle 5 is not subject to the HMR as a Division 2.2 non-flammable gas. Moreover, it is the opinion of this Office that the FreeStyle 5 device and the lithium ion batteries contained in the device appear to conform to 49 CFR 172.102(c)(1), Special provision 188 (SP 188), for the transportation of small lithium cells and batteries. Thus, provided the conditions in SP 188 continue to be met, the FreeStyle 5 is not subject to any other requirements in the HMR.

Although the exception in 49 CFR 175.10(a)(18) would apply to a passenger transporting a lithium battery-powered portable oxygen concentrator, the approval of the Federal Aviation Administration (FAA) is required before it may be operated onboard an aircraft.

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

Sincerely,

 

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

172.102 SP 188, 175.10(a)(18)

Regulation Sections

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