Data / Medical devices / United States / Thousand Solutions Inc.
Thousand Solutions Inc.: FDA-registered device maker in San Sebastian, PR, United States, 4 510(k) clearances
Thousand Solutions Inc. is registered with the FDA (registration 3039878168) in San Sebastian, PR, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 12, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039878168
- Address
- Carr. 125 KM 16.9 Interior Bo. Pozas, San Sebastian, PR, United States, 00685
- Owner or operator
- Thousand Solutions Inc. (10093976)
- Roles
- Repackager or relabeler
- First device listed
- August 27, 2025
- Registered through
- 2026
- Brand names listed
- Prudence Caribbean MIX sensitive C20, Prudence Caribbean MIX sensitive C5, Prudence Clasico C20, Prudence Clasico C3, Prudence Fresa C3, Prudence Gel sabor y aroma Fresa, Prudence Gel sabor y aroma Natural, Prudence Mora C3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal | NUC | 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 |
|---|---|---|---|---|---|---|
| November 12, 2015 | K150743 | Water Based Personal Lubricant with Flavours | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| September 24, 2004 | K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| December 19, 2000 | K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated November 12, 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.