Data / Medical devices / United States / Prapela, Inc.
Prapela, Inc.: FDA-registered device maker in Portland, ME, United States, 1 510(k) clearance
Prapela, Inc. is registered with the FDA (registration 3048181753) in Portland, ME, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3048181753
- Address
- 2 Monument Sq Ste 400, Portland, ME, United States, 04101
- Owner or operator
- Prapela, Inc. (10096199)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 21, 2026
- Registered through
- 2026
- Brand names listed
- Prapela SVS Hospital Bassinet Pad (Model P01)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome | QVY | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 4, 2025 | DEN240031 | Prapela SVS hospital bassinet pad (model P01) | QVY | Unknown | Prapela, Inc. | accessdata.fda.gov |
Updated April 4, 2025. 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.