Data / Medical devices / United States / Sleep Specialists, LLC
Sleep Specialists, LLC: FDA-registered device maker in Bala Cynwyd, PA, United States, 1 510(k) clearance
Sleep Specialists, LLC is registered with the FDA (registration 3008812550) in Bala Cynwyd, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 11, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008812550
- Address
- 150 Monument Rd Ste 207, Bala Cynwyd, PA, United States, 19004
- Owner or operator
- 2z Medical (10034700)
- Roles
- Specification developer
- First device listed
- December 23, 2010
- Registered through
- 2026
- Brand names listed
- Zzoma, Zzoma Positional Device, Zzoma Positional Sleeper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pillow, Cervical (For Mild Sleep Apnea) | MYB | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 11, 2010 | K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | MYB | Substantially Equivalent | Sleep Specialists, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 11, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.