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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 from 

AC or external DC power sources as well as a replaceable 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 Administration (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 ownership 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.com 
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per FDA guidance document K97-1 “Deciding when to submit a 510(k) for a change to an existing 

device”. [See Appendix C for non-filing justification]. 

PHMSA Letter of Interpretation 

On September 15, 2015 the Pipeline and Hazardous Materials Safety Administration (PHMSA) 

provided a written interpretation to Oxus confirming 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 operator approval; and the Zen-O® contains no 

other hazardous materials. Therefore, the Zen-O® POC 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 the 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 Model 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. Zen-O® POC Model RS-00500 POC has been tested to 

ensure it does not cause interference with the electrical, navigation, or communication equipment on the 

aircraft on which it is to be used. The Zen-O® POC Model RS-00500 POC has been tested in accordance with 

RTCA DO-160 Rev G Section 20 (Radiated, Radio-Frequency, Electromagnetic Immunity), Section 21 

(Radiated Emissions), and Section 25 (Electro-Static Discharge Immunity Test). The Zen-O® complies with 

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 included to instruct patients before traveling in an aircraft to 

comply with section 3(a) and 3(b). The current user manual will be revised to include the following 

information: 

1. The patient must be capable of hearing the unit's alarms, seeing the alarm light indicators, and have 

the cognitive ability to take the appropriate action in response to the various caution and warning 

alarms and alarm light indicators, or be travelling with someone who is capable of performing those 

functions 
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2. The patient must ensure that the portable oxygen concentrator is free of oil, grease or other 

petroleum products and is in good condition free from 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 the 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 physical and cognitive ability to see, hear, and 

understand the device's aural and visual cautions and warnings and is able, without 

assistance, to take the appropriate action in response to those cautions and warnings 

b. States whether or not oxygen use is medically necessary for all or a portion of the duration 

of the trip; and 

c. Specifies the maximum oxygen flow rate corresponding to the pressure in the cabin of the 

aircraft under normal operating conditions 

4. Person using a POC must not be seated in an emergency exit row or any row that restricts any 

passenger's access to, or use of, any required emergency or regular exit, or the aisle(s) in the 

passenger compartment. If patients are not required to use oxygen during takeoff, landing, or 

movement on the surface, they must stow the POC according 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-off. 

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) submission is 

approved by the FDA. 

2. The	POC	may	not	contain	hazardous	materials	as	determined	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	interference	with	the	electrical,	navigation	or	

communication	equipment	on	the	aircraft	on	which	the	device	is	to	be	used. Appendix E provides 

compliant results for testing in accordance with RTCA standard 160G, Section 21, Category M 

Based upon the information provided above, we respectfully submit the information contained in this 

petition should be sufficient to amend Section 2 and Section 3(a) of SFAR No. 106 to include the Zen-O® 

POC Model RS-00500 as an approved portable oxygen concentrator for use onboard an aircraft. 
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Thank you in advance for your time and consideration pertaining to this request. Please advise with any 

comments, questions, or concerns you may have by phone at 248-475-0925, by email at 

rlenarcic@oxusamerica.com, or by fax at 248-475-0938. 

Sincerely, 

Ryan Lenarcic 

Quality Manager 

OXUS AMERICA