Zzoma
GUDID 00863826000315
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).
2Z Medical
Sleep apnoea pillow| Primary Device ID | 00863826000315 |
| NIH Device Record Key | 4d3454d1-dca1-4183-b9da-76776edf2e0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zzoma |
| Version Model Number | 001 |
| Company DUNS | 829477228 |
| Company Name | 2Z Medical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com | |
| Phone | 877 799 9662 |
| info@2zmedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863826000315 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100160
FDA Product Code
| MYB | Pillow,Cervical(For Mild Sleep Apnea) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-11 |
Trademark Results [Zzoma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZZOMA 77489695 3642232 Live/Registered |
Sleep Specialists, LLC 2008-06-03 |
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