Data / Medical devices / United States / JW North America, Inc.
JW North America, Inc.: FDA-registered device maker in Rockland, MA, United States, 4 510(k) clearances
JW North America, Inc. is registered with the FDA (registration 1450790) in Rockland, MA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated October 30, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1450790
- Address
- 200 Ledgewood Place Suite 201, Rockland, MA, United States, 02370
- Owner or operator
- JW North America, Inc (10027891)
- Roles
- Specification developer
- First device listed
- February 25, 2020
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 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 |
|---|---|---|---|---|---|---|
| October 30, 2015 | K152273 | Cosmedico Ultraviolet Lamps of Various Models | LEJ | Substantially Equivalent | Cosmedico Light, Inc. | accessdata.fda.gov |
| October 28, 2015 | K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) | LEJ | Substantially Equivalent | Cosmedico Light, Inc. | accessdata.fda.gov |
| October 20, 2015 | K151674 | Ultraviolet Sun Tanning Lamp | LEJ | Substantially Equivalent | G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh | accessdata.fda.gov |
| October 5, 2015 | K151841 | Ultraviolet Sunlamps | LEJ | Substantially Equivalent | Wolff System Technology Corp. | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2015. 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.