Portable Liquid Oxygen Unit Stand
The Portable Liquid Oxygen Unit Stand is a physical medicine accessory device designed to assist the user with refilling a portable liquid oxygen tank from a reservoir unit by securely holding the portable liquid oxygen unit in the correct position during the transfer process. It falls under the Physical Medicine medical specialty and is classified as a Class 1 device under regulation 890.5050, subject to general controls with a low regulatory burden. It is not an implant and is not life-sustaining.
Research product code PCM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PCM
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
Definition
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121661 | EZ-ASSIST-FILL | Dec 27, 2012 | Substantially Equivalent | Assist Fill, LLC |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.