Data / Medical devices / United States / JMBH Holdings LLC
JMBH Holdings LLC: FDA-registered device maker in Shelton, CT, United States, 1 510(k) clearance
JMBH Holdings LLC is registered with the FDA (registration 3042823784) in Shelton, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042823784
- Address
- 3 Enterprise Dr Ste 112, Shelton, CT, United States, 06484
- Owner or operator
- JMBH Holdings LLC (10094869)
- Roles
- Repackager or relabeler
- First device listed
- December 30, 2025
- Registered through
- 2026
- Brand names listed
- Playtex H15
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 20, 2022 | K212884 | Electric breast pump | HGX | Substantially Equivalent | Dongguan Rongfeng Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 20, 2022. 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.