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OCTOBER 7, 2015



### Federal Docket Management System (FDMS)

Shell Docket FAA-2007-0001

Dear Sir or Madam:

Please accept this letter as petition to amend the Federal Aviation Administration's (FAA) Special Federal Aviation Regulation (SFAR) No. 106 under 14 CFR 121 that allows for the use of certain portable oxygen concentrator (POC) devices onboard passenger aircraft. Oxus is specifically requesting that the FAA amend Section 2 and Section 3(a) of SFAR No. 106 by adding Oxus’ portable oxygen concentrator model RS-00500, tradename Zen-O ®, as one of the approved POC devices for use on passenger aircraft.

Background

The Zen-O® Model Number RS-00500 POC is for oxygen delivery to patients that require ambulatory supplemental oxygen therapy and utilizes molecular sieve / Pressure Swing Absorption (PSA) technology. The POC is designed to be used in many environments including but not limited to the patient’s home, car, train, and aircraft. The Zen -O® POC is self-sufficient, capable of operation fr om AC or external DC power sources as well as a replac eable battery. This model is comprised of the same technology as our previously approved Model Number RS-00400 POC.

FDA Clearance Letter
On January 3, 2008, the Food and Drug Administratio n (FDA) issued a 510(k) premarket notification letter K073242 that determines the RS-00400 POC is substantially equivalent to a legally marketed predicate device and may start to market the device [See Appendix A]. On February 10, 2012 SFAR No. 106 was updated to reflect the transfer of ownershi p from Delphi to Oxus for Model RS-00400 [See Appendix B]. The Zen-O® Model Number RS-00500 POC does not require a new 510(k) submission Oxus America 2676 Paldan Dr Auburn Hills, MI 48326 Tel 248-475-0925 Fax 248-475-0938 rlenarcic@oxusamerica.com www.oxusamerica.comPage 2

per FDA guidance document K97-1 “Deciding when to s ubmit a 510(k) for a change to an existing device”. [See Appendix C for non-filing justificat ion].

PHMSA Letter of Interpretation

On September 15, 2015 the Pipeline and Hazardous Ma terials Safety Administration (PHMSA) provided a written interpretation to Oxus confirmin g that the Zen-O® Model Number RS-00500 is not subject to the U.S. hazardous material regulations (HMR) as a Division 2.2 non-flammable gas. Furthermore, the lithium ion battery pack conforms to § 175.10(a)(18), excluding lithium ion batteries with a Wh rating between 100 and 160 that require o perator approval; and the Zen-O® contains no other hazardous materials. Therefore, the Zen-O® P OC is allowed to be transported by passengers in accordance with the HMR. [See Appendix D].

Performance and Safety

During the design & development phases of the Zen-O ® project launch, the model number and/or marketing name was not be released. This was done to protect the organization and supply base from inadvertently releasing sensitive information to th e market prior to product release. For this case, the POC was launched under the code name “Project Dumog”. Therefore, any documents denoting the following nomenclature relate directly to the Zen-O® POC Mode l RS-00500: Project Dumog, Dumog, Zen-O®, and RS00500.
The Zen-O® POC Model RS-00500 POC has been designed to comply with 14 CFR Parts 121, 125, and 135 Special Federal Aviation Regulation (SFAR) 106. Ze n-O® POC Model RS-00500 POC has been tested to ensure it does not cause interference with the elec trical, navigation, or communication equipment on t he aircraft on which it is to be used. The Zen-O® POC Model RS-00500 POC has been tested in accordance wi th RTCA DO-160 Rev G Section 20 (Radiated, Radio-Frequ ency, Electromagnetic Immunity), Section 21 (Radiated Emissions), and Section 25 (Electro-Stati c Discharge Immunity Test). The Zen-O® complies wi th these testing standards [See Appendix E].

The Zen-O® POC Model RS-00500 user manual includes instructions that meet sections 3(a) (1 and 2) of SFAR No. 106. Additional instructions will be incl uded to instruct patients before traveling in an ai rcraft to comply with section 3(a) and 3(b). The current use r manual will be revised to include the following information:

1. The patient must be capable of hearing the unit's a larms, seeing the alarm light indicators, and have the cognitive ability to take the appropriate actio n in response to the various caution and warning alarms and alarm light indicators, or be travelling with someone who is capable of performing those functionsPage 3 2. The patient must ensure that the portable oxygen co ncentrator is free of oil, grease or other

petroleum products and is in good condition free fr om damage or other signs of excessive wear or abuse. 3. The patient must inform the aircraft operator that he or she intends to use a portable oxygen concentrator on board the aircraft and must allow t he crew of the aircraft to review the contents of the physician's statement. The patient must have a written statement, to be kept in that person's possession, signed by a licensed physician that:

a. States whether the user of the device has the physi cal and cognitive ability to see, hear, and understand the device's aural and visual cautions a nd warnings and is able, without assistance, to take the appropriate action in respo nse to those cautions and warnings b. States whether or not oxygen use is medically neces sary for all or a portion of the duration of the trip; and

c. Specifies the maximum oxygen flow rate correspondin g to the pressure in the cabin of the aircraft under normal operating conditions 4. Person using a POC must not be seated in an emergen cy exit row or any row that restricts any passenger's access to, or use of, any required emer gency or regular exit, or the aisle(s) in the passenger compartment. If patients are not require d to use oxygen during takeoff, landing, or movement on the surface, they must stow the POC acc ording to airline regulations. 5. Carry sufficient battery to last for the entire tip , including layovers and or flight delays. 6. Batteries, not being used or extra, must be stowed in its protective cover or/and placed inside the carrying case or placed inside an approve carry-on baggage, packaged to prevent short-circuits and protected from physical damage. 7. In the event of an alarm, the POC must be turned-of f. 8. Only oxygen approved lotions or salves may be used by the patient.

Synopsis and Submission:

In summary, the following aspects are included for the Zen-O® POC Model RS-00500:

1. The	POC	must	be	regulated	by	the	FDA . Appendix A, B, and C confirm the 510(k) submissi on is approved by the FDA.

2. The	POC	may	not	contain	hazardous	materials	as	dete rmined	by	the	Pipeline	and	Hazardous	Materials Safety	Administration	(PHMSA) . Appendix D provides the Letter of Interpretation from PHMSA confirming that the POC does not contain hazardous materials.

3. Operator	must	determine	that	POC	does	not	cause	int erference	with	the	electrical,	navigation	or communication	equipment	on	the	aircraft	on	which	th e	device	is	to	be	used . Appendix E provides compliant results for testing in accordance with RT CA standard 160G, Section 21, Category M

Based upon the information provided above, we respe ctfully submit the information contained in this petition should be sufficient to amend Section 2 an d Section 3(a) of SFAR No. 106 to include the Zen-O ® POC Model RS-00500 as an approved portable oxygen c oncentrator for use onboard an aircraft.Page 4

Thank you in advance for your time and consideratio n pertaining to this request. Please advise with a ny comments, questions, or concerns you may have by ph one at 248-475-0925, by email at rlenarcic@oxusamerica.com, or by fax at 248-475-093 8.

Sincerely,

Ryan Lenarcic Quality Manager OXUS AMERICA