Device
An intraoral OSA device with an embedded oximeter used for remote physiologic monitoring.
Manufacturer
PROSOMNUS SLEEP TECHNOLOGIES
PROSOMNUS SLEEP TECHNOLOGIES
Model: RPMO2 OSA
DI: 00850022853036
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
An intraoral OSA device with an embedded oximeter used for remote physiologic monitoring.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a6942b45-3d4d-4904-a2a5-9a96b1c28daa
Distribution Status:
In Commercial Distribution
DUNS Number:
075438768
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850022853036
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47526
Name: Mandible-repositioning sleep-disordered breathing orthosis
Definition:
A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.
FDA Product Codes
DQA
Oximeter
LQZ
Device, Jaw Repositioning
LRK
Device, Anti-Snoring
OUG
Medical Device Data System
PLC
Sleep Appliances With Patient Monitoring
Premarket Submissions
Submission Number:
K252765
Supplement Number:
000