Interpretation Response #10-0241 ([Oxus, Inc.] [Mrs. Joan Rolwing])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Oxus, Inc.
Individual Name: Mrs. Joan Rolwing
Location State: MI Country: US
View the Interpretation Document
Response text:
December 17, 2010
Mrs. Joan Rolwing
Oxus, Inc.
1685 Northfield Dr.
Rochester Hills, MI 48309
Ref. No.: 10-0241
Dear Mrs. Rolwing:
This responds to your November 5, 2010 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to lithium battery requirements. You indicate that your company, Oxus, Inc., has purchased the design, process, inventory, and all rights to the Delphi Medical Systems device "Portable Oxygen Concentrator, Model RS-00400." In 2008, Delphi Medical Systems requested a letter of interpretation from this Office pertaining to whether this product complied with Special Provision 188 and was not otherwise subject to the HMR (08-0034). Specifically, you ask if PHMSA will reconfirm whether this product is in compliance with the HMR.
In your letter, dated 11/5/2010, you indicate the Oxus, Inc. "Portable Oxygen Concentrator, Model RS-00400" and external battery module continues to meet the following criteria:
(1) the pressure of the oxygen in the device does not exceed 40.6 psia at 20 °C;
(2) the cells contain not more than 1.5 grams of lithium equivalent content;
(3) the lithium ion batteries contain an aggregate equivalent lithium content of not more than 8g;
(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 above, the Oxus, Inc. portable oxygen concentrator and external battery module meet Special Provision 188. Provided they continue to meet the requirements established by Special Provision 188, you are not otherwise subject to the HMR.
I trust this satisfies your inquiry. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
172.102 SP 188
Regulation Sections
| Section | Subject |
|---|---|
| 173.185 | Lithium cells and batteries |