Data / Medical devices / Japan / Okamoto Industries, Inc.
Okamoto Industries, Inc.: FDA-registered device maker in Ryugasaki-Shi, Ibaraki-Pref, Japan, 4 510(k) clearances
Okamoto Industries, Inc. is registered with the FDA (registration 3006122980) in Ryugasaki-Shi, Ibaraki-Pref, Japan. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006122980
- Address
- No.1, Nishiyama-Itabashi-Cho, Ryugasaki-Shi, Ibaraki-Pref, Japan, 301-0801
- Owner or operator
- OKAMOTO INDUSTRIES, INC. (8031642)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 17, 2002
- Registered through
- 2026
- Brand names listed
- 04 HA, 04 ZERO ZERO FOUR, Beyond BodiHeat, HEAT THERAPY, WINK Closer, WINK Slider
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | 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 4, 2026 | K252622 | Male Latex Condom HA | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| February 25, 2022 | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | MOL | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| July 24, 2020 | K192669 | Extremely Thin 003, ZERO ZERO THREE | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| March 31, 2009 | K090259 | OKAMOTO ULTRA THIN | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 4, 2026. 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.