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Zzoma

FDA UDI

Class II (US FDA UDI)

by 2Z Medical

Identity

Trade Name
Zzoma FDA UDI
Generic Name
Sleep apnoea bed pillow FDA UDI
Device Name
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA). FDA UDI
Model / Reference
001 FDA UDI
Description
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA). FDA UDI

Identifiers

Primary DI / UDI-DI
00863826000315 FDA UDI
510(k) Number
K100160 FDA UDI
FDA Product Code
MYB FDA UDI
GMDN Term
Sleep apnoea bed pillow 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Sleep apnoea bed pillow

Zzoma by 2Z Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sleep apnoea bed pillow.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
2Z Medical

Sources (1)

  • FDA UDI 4d3454d1-dca1-4183-b9da-76776edf2e0e 35 fields · synced Jun 6, 2026