← Back to catalogue

Ema Appliance

FDA UDI

Class II (US FDA UDI)

by Ortho Solutions LC

Identity

Trade Name
EMA APPLIANCE FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
EMA ORAL SLEEP APNEA APPLIANCE FDA UDI
Model / Reference
0484 FDA UDI
Description
EMA ORAL SLEEP APNEA APPLIANCE FDA UDI

Identifiers

Primary DI / UDI-DI
D84104841 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

Ema Appliance by Ortho Solutions LC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ortho Solutions LC

Sources (1)

  • FDA UDI cf30193a-da4e-42e5-94c3-40a0bf4f744a 33 fields · synced May 30, 2026