FDA.reportPublic FDA data

Zzoma

Primary DI
00863826000315
Brand
Zzoma
Company
2Z Medical
Model
001
Device description
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYBPillow,Cervical(For Mild Sleep Apnea)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYBPillow, Cervical (For Mild Sleep Apnea)Dental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100160000ZZOMA POSITIONAL SLEEPER MODEL 001Sleep Specialists, LLC2010-05-11MYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863826000315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863826000315008638260003158638260003150863826000315

GMDN Terms#

Term, Definition table
TermDefinition
Sleep apnoea pillowA specially designed cushion used to support the head and neck (the cervical region) in a position that is similar to that used in cardiopulmonary resuscitation (CPR), so that the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnoea. It may also be used to help reduce snoring and improve the quality of sleep. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877 799 9662info@2zmedical.com

Regulatory Flags#

DUNS number
829477228
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034296Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034319Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034326Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034333Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034357Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034340Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-11-14
70850015266194Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-10-27
00850063034302Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-08-21
00850063034272Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034289Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034265Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-05-22
10850015266192Night ShiftADVANCED BRAIN MONITORING, INC.MYB2024-03-14
00850015266492Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266508Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266515Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266195Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266218Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266232Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
20850015266199Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
30850015266196Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
40850015266193Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
50850015266190Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
60850015266197Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
80850015266191Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00606959054615NightBalanceRespironics, Inc.MYB2020-12-15
00606959054639NightBalanceRespironics, Inc.MYB2020-12-15
30606959054616NightBalanceRespironics, Inc.MYB2020-12-15
30606959054630NightBalanceRespironics, Inc.MYB2020-12-15
00850015266072Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30
00850015266089Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30