Interpretation Response #08-0229 ([DeVibiss Healthcare] [Mr. David Greene])

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

Interpretation Response Details

Response Publish Date: 11/26/2008

Company Name: DeVibiss Healthcare

Individual Name: Mr. David Greene

Location State: PA Country: US

View the Interpretation Document

Response text:

November 26, 2008

Mr. David Greene

DeVibiss Healthcare

100 DeVilbiss Drive

Somerset, PA 15501-2125

Ref. No. 08-0229



Dear Mr. Greene:



This responds to your letter dated August 25, 2008 regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a device your company calls the iGo Portable Oxygen Concentrator (POC).

According to your letter the iGo Portable Oxygen Concentrator is a device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen. The device is light and capable of operating from an installed lithium ion battery pack. The device has a maximum operating pressure of 14 psia and is equipped with a pressure relief device designed to operate at 20 psia ± 3 psia. The lithium ion battery pack contains less than 8 grams equivalent lithium content and is a type proven to meet the requirements of each test in the UN Manual of Tests and Criteria. Though the lithium ion battery is excepted from the HMR, it must satisfy the requirements of § 173.21(c) which states that an electrical device is forbidden for transportation unless it is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals).

Based on the information provided, the iGo portable oxygen concentrator is not currently subject to the HMR because it meets the following criteria:

(1) The pressure of the oxygen in the device does not exceed 40.6 psia at 20°C;

(2) The lithium ion battery used to operate the device is excepted from the HMR;

(3) The portable oxygen concentrator 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 (for example, by the effective insulation of exposed terminals).

You should also note Federal Aviation Administration (FAA) approval is required before these electronic devices are 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).

In addition, even with FAA approval the air carrier ultimately determines what may or may not be carried on its aircraft. We suggest that you check with the air carrier to ensure that the iGo portable oxygen concentrator may be carried.

I hope this satisfies your inquiry. If we can be of further assistance, please contact us.

Sincerely,

Charles E. Betts

Chief, Standards Development

Office of Hazardous Materials Standards

173.21(c), 173.185

Regulation Sections