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Interpretation Response #11-0229 ([Inogen, Inc.] [Mr. Matt Scribner])

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

Interpretation Response Details

Response Publish Date:

Company Name: Inogen, Inc.

Individual Name: Mr. Matt Scribner

Location State: CA Country: US

View the Interpretation Document

Response text:

October 13, 2011

Mr. Matt Scribner
Vice President of Operations
Inogen, Inc.
326 Bollay Drive
Goleta, CA 93117

Ref. No. 11-0229

Dear Mr. Scribner:

This responds to your September 16, 2011 email requesting clarification of the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator. You request confirmation that the Inogen One G3 portable oxygen concentrator (heretofore referred to as the G3) is not subject to the HMR.

Your company requested interpretations in 2004 and 2009 on the applicability of the HMR to previous generations of the G3. In our August 6, 2009 letter response, we stated that, provided the conditions in § 172.102, Special Provision 188 (SP 188) are met, the Inogen One G2 portable oxygen concentrator is not subject to further requirement under the HMR.

According to information provided with this request, your company has made modifications to Inogen One G2 resulting in the G3 design "without any functional changes that affect the overall safety of the device or its safe use on commercial aircraft." The most significant change to the G3 is a smaller battery. The G3 uses an 8-cell lithium ion battery pack and provides an optional extended life battery consisting of two 8-cell battery packs that are electrically isolated and mechanically separated when enclosed in the device. Specifically, you state: (1) each lithium ion cell has an equivalent lithium content of 0.87 gram; (2) the total equivalent lithium content of each 8-cell battery pack is 7 grams (~83.5 Wh); (3) the batteries are contained in the device and packaged in a manner to prevent sparks or the generation of a dangerous evolution of heat; (4) the pressure of the oxygen in the device is limited to less than 43.8 psia at 20 °C (68 °F); and (5) no other hazardous material subject to the HMR is contained in the device.

Based on the information provided, the oxygen in the G3 is not subject to the HMR as a Division 2.2 non-flammable gas. Moreover, it is the opinion of this Office that the
G3 device and the lithium ion batteries contained in the device appear to conform to SP 188 for the transportation of small lithium cells and batteries. Note that as one of the conditions of SP 188, the lithium ion batteries must be of a type proven to meet the requirements of testing in the UN Manual of Tests and Criteria. Thus, provided the conditions in SP 188 continue to be met, the G3 is not subject to any other requirements in the HMR.

As in our previous responses, we note that, even with FAA approval, an air carrier ultimately determines what may or may not be carried on its aircraft. We suggest that you check with the airlines to ensure that the G3 may be carried aboard passenger aircraft.

I hope this information is helpful. If you have further questions, please do not hesitate to contact this office.

Sincerely,

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

172.102 SP 188

Regulation Sections

Section Subject
173.185 Lithium cells and batteries