# K100160: Zzoma Positional Sleeper Model 001

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Specialists, LLC
- Decided: May 11, 2010 after 111 days
- Product code: MYB (Pillow, Cervical (For Mild Sleep Apnea))
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023010 (2002). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040161: Sona Pillow, Sleep Devices, Inc. (2004) Summary page 1.
- K023010: Sniff Position Pillows/Popitz Pillows, Aeolus International Corporation (2002) Summary page 1.

## Most influential descendants
- K140190: Night Shift (2014), 1 descendant of its own
- K180608: Lunoa System (2018), 0 descendants of its own

## Indications for use
The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring. The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K100160
Methodology: https://510kreport.com/methodology