Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010197101

FEI Number

3010197101

Entity Name

CEGA INNOVATIONS, INC.

City/State/Country

Sioux Falls, SD, US

Establishment Address

4920 E. 57 St., Sioux Falls, SD 57108, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CEGA Innovations, Inc. (Owner Number: 10043896)

Owner / Operator Contact Address

4920 E. 57 St., Sioux Falls, SD 57108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MUV Board MUV Transfer System MUV MUV System REMUV Air Transfer System REMUV Patient Transfer System REMUV Air Elite REMUV System REMUV MUV Prime Prime MUV Elite REMUV LP REMUV Lithotomy Position HALO Air Mat HALO HALO Reusable HALO Single Patient Use HALO Reusable Air Transfer Mattress HALO Single Patient Use Air Transfer Mattress HALO Single Patient Use (SPU) Air Transfer Mattress Skin Integrity Pad MUV Multi-Purpose Pad SIP Pad MUV MP Pad MUV Sheet SIP REMUV SIP MP PAD Breathable SIP Breathable Skin Integrity Pad Breathable Skin Integrity Pad (SIP) Premium Breathable Skin Integrity Pad Premium Breathable Skin Integrity Pad (Repositioning)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2013-04-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2013-05-09

Official Correspondent

Aaron Emerson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CEGA Innovations, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197101. Last updated year: 2026. Please use registration number 3010197101 when referencing this establishment in official correspondence.