Sleep Specialists, LLC

FDA Device Registration & Listing · Bala Cynwyd, PA, US · Registration 3008812550

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008812550
FEI Number
3008812550
Entity Name
Sleep Specialists, LLC
City/State/Country
Bala Cynwyd, PA, US
Establishment Address
150 Monument Rd Ste 207, Bala Cynwyd, PA 19004, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
2z Medical (Owner Number: 10034700)
Owner / Operator Contact Address
150 Monument Road, Suite 207, Room 222, Bala Cynwyd, PA 19004, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K100160
PMA Number
N/A

All Registered Proprietary Names

Zzoma Zzoma Positional Device Zzoma Positional Sleeper

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MYB Pillow, Cervical (For Mild Sleep Apnea) Dental Class 2 872.5570 2010-12-23

Official Correspondent

Michael Markus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

2z Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100160 Sleep Specialists, LLC ZZOMA POSITIONAL SLEEPER MODEL 001 2010-05-11
K180608 Nightbalance BV Lunoa System 2018-06-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008812550. Last updated year: 2026. Please use registration number 3008812550 when referencing this establishment in official correspondence.
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