05:48:31P.m. 01-08-2009 213 202 366 7041 

# @

U.5. Depanment of Transportataon Pipeline and Hazardoos

Materials Safety Mministration !200 New Jerssy Ave., SE Washrngton,

DC 20590 

## JAN 0 I 2009

Mr. William R. Wilkinson Vice President

of Engineering International

Biophysics

Corporation

0BC) 2100 East St. Elmo Rd. Austin, TX787M Ref. No.08-0266 Dear Mr. Wilkinson: This is in response

to your October

13, 2008 letter regarding the applicability

of theHazardous Materials

Regulations

(HMR; 49 CFR Parts

100-180) to a device

your company calls the LifeChoice

Portable Oxygen Concentrator

(POC). You state

in your letter

and a subsequent

conversation

with a member

of my staff

that the LifeChoice

POC is a lightweight

device thatseparates

nitrogen from room air through

the pressure swing absorption

(PSA) prooess and stores the resultant

concentrated

oxygen gas for delivery

to patients requiring supplemental

oxygen. Thisdevice

delivers the oxygen to the patient hrough the pulse dose delivery method. The maximum

interndlly

attainable

pressure during the PSA cycle of the device is 22 psig(36.7

psia) over anoperating

temperature

range of 5 oC to 40 "C (41 'F to 104 "F), with a maximum

oxygen accumulator

quantity of 45 mil per

minute for operation

in thepulse mode. Thedevice

can be powered

by multiple

power sources, including an internally

captive, rechargeable

lithium ion battery

pack, AC to DC power

adaptor, by anexternal

DC to DC power adapter, or an external

accessory

lithium ion battery

pack. The internally

captive lithium ion battery consisls of 8 rechargeable2.2

amp-hour

tithiumion cells

with 0.3 grams of lithium

content each, or a total of 5.2 glarns

of total equivalent

lilhiumcontent

(0.3 x2.2 Ah x 8 cells),

and no other hazardous

materials.

The external

accessory

battery module consists of two battery

packs, each containing

a totalof 5.2grams

of total equivalent

lithium content, or a total of 10.4 grarns of total equivalent

lithium content.

The lithiumion battery

pack has been tested pursuant to the United Nations Manual of Tests and Criteria and 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 as a hazardous

material under theHMR. Based on the information

provided,

theLifeChoice

POC is not currently subject o the HMR because it meets the following

criteria: l. The pressure

of the oxygen in the device does not exceed

280kPa (a0.6 psia) at 20 "C (68 "F); 2. The lithium ion batteries used to operate

the device are excepted in theHMR;05r48:52p.m. 01-08-2009

3. The portable

oxygen concentmtor

contains no other materials subject to the HMR; and 4. The battery

pack is packaged

in a rnanner

to preclude

it from creating

sparks or generating

a dangerous

quantity of heal (for example,

by the effective insulation

of exposed

terminals). You should

also note Federal Aviation Administration

(FAA) approval

is required

before thesc electronic

devices are used by passengers

on board aircraft. The FAA published

a final rule in the Federal Register egarding

these devices on July 12,2005

(70 FR 40156).

Forfurther

assistance, you maycontact

Mr. Dave

Catoy, Aviation Safety Inspector for theFAA Air Carrier

Operations Branch (AFS-220)

by phone at (202)-267-3732

or emailar dqy1.d.!4lgJ@,tac€!l. In addition,

even with FAA approval

the air carrier

ultimately

determines

whatmay

or may not be carried on its aircraft.

We suggest

that youcheck

with the air carrier

to ensure that the LifeChoice portable oxygen concenkator

may be carried. I hope this satisfies

your inquiry. If we can

be of further

assistance,

please contact us.

Hattie L. Mitchell Chief, Regulatory

Review andReinvention Office of Hazardous

Materials Standards 3t3 202 366 7041