Interpretation Response #11-0044 ([O2 Concepts, LLC] [Ms. Kathryn G. Forgione])

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

Interpretation Response Details

Response Publish Date: 03/23/2011

Company Name: O2 Concepts, LLC

Individual Name: Ms. Kathryn G. Forgione

Location State: OK Country: US

View the Interpretation Document

Response text:

March 23, 2011

Ms. Kathryn G. Forgione
Vice President of Quality
O2 Concepts, LLC
14001 McAuley Blvd., Suite 170
Oklahoma City, OK 73134

Ref. No.: 11-0044

Dear Ms. Forgione:

This responds to your February 15, 2011 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator. Specifically you ask if the OxLife Independence oxygen concentrator is compliant with Special Provision 188. For your information, in December 2008 this office responded to a similar request for interpretation from OxLife, LLC (Ref. No. 08-0237). In your letter you indicated that in 2010 your company purchased the appropriate legal rights to the OxLife Independence oxygen concentrator.

The information you provided in your letter, reiterates that provided by OxLife LLC in 2008 concerning the contents of the OxLife Independence oxygen concentrator. You indicate the following:

1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 degrees C;
2. The cells contain no more than 1.5 grams of lithium equivalent content;
3. The lithium ion battery contains an aggregate equivalent lithium content of not more than 8 g;
4. The device contains no other materials subject to the HMR; and
5. The batteries are fully contained in equipment and packaged in a manner to preclude sparks or the generation of a dangerous quantity of heat.

Based on the information provided, the OxLife Independence portable oxygen concentrator meets the requirements of Special Provision 188. Provided it continues to meet the requirements established in Special Provision 188, it is not otherwise subject to the HMR.

You should also note that Federal Aviation Administration (FAA) approval is required before these electronic devices may be used by passengers on board aircraft. The FAA published a final rule in the Federal Register regarding these devices on July 12, 2005 (70 FR 40156). A copy of the rulemaking is enclosed.

I hope this answers your inquiry. If you need additional assistance, please contact the Standards and Rulemaking Division at 202-366-8553.

Sincerely,

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

Enclosure

172.102 SP 188

Regulation Sections