510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100160Substantially Equivalent

Zzoma Positional Sleeper Model 001

Sleep Specialists, LLC, Greenville DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100160 is the FDA 510(k) clearance record for ZZOMA POSITIONAL SLEEPER MODEL 001, a class II device, cleared for Sleep Specialists, LLC on under FDA product code MYB (Pillow, Cervical (For Mild Sleep Apnea)). FDA records list one 510(k) clearance for Sleep Specialists, LLC. As of , FDA records show no recalls naming K100160.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MYB Pillow, Cervical (For Mild Sleep Apnea)
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Sleep Specialists, LLC 1 Congressional Dr., Greenville DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYB

Trailing 12 months

FDA records hold no clearances under product code MYB in the trailing twelve months.

FDA records show no clearances under product code MYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MYB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260