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Sign in to claim this brandOKAMOTO USA, INC.
US
Last updated May 27, 2026
What OKAMOTO USA, INC. makes
OKamoto USA, Inc. manufactures single-use latex male condoms in various sizes and designs, including standard, extra-large, and color-assorted varieties, as well as reusable hot/cold therapy packs for localized temperature treatment.
The company’s products are regulated under FDA classifications, with condoms falling under Class I and some thermal therapy packs classified as Class II. These devices are listed via the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) system, ensuring compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does OKamoto USA, Inc. manufacture?
OKamoto USA, Inc. primarily manufactures two main types of devices: single-use latex male condoms in various sizes and designs (such as standard, extra-large, and color-assorted varieties) and reusable hot/cold therapy packs for localized temperature treatment. These products are designed for different consumer needs, with condoms serving as a barrier contraceptive and the therapy packs providing thermal relief.
Where is OKamoto USA, Inc. based, and how does that affect its regulatory compliance?
OKamoto USA, Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since the company’s products fall under FDA classifications—condoms as Class I and thermal therapy packs as Class II—they must comply with U.S. medical device regulations, including mandatory listing via the FDA’s 510(k) pathway and Unique Device Identifier (UDI) system.
Which regulatory registries or databases list OKamoto USA, Inc.’s devices?
OKamoto USA, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices under U.S. regulatory oversight, confirming compliance with FDA requirements for both condoms (Class I) and thermal therapy packs (Class II).
How are OKamoto USA, Inc.’s devices classified under FDA regulations?
OKamoto USA, Inc.’s devices are classified based on their risk levels and intended use. Basic male condoms fall under Class I, which typically includes low-risk devices requiring general controls for safety and effectiveness. In contrast, the company’s hot/cold therapy packs are classified as Class II, indicating a moderate risk that necessitates special controls beyond general regulations to ensure their safe and effective performance.
Why do some of OKamoto USA, Inc.’s devices require a Unique Device Identifier (UDI)?
The FDA mandates a Unique Device Identifier (UDI) for all medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Since OKamoto USA, Inc.’s devices—including both condoms and thermal therapy packs—are listed under the FDA’s UDI system, each product is assigned a unique code that distinguishes it from others, ensuring accurate identification in regulatory databases and clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- okamotousa.com
- —
- —
- [email protected]
- Phone
- 1-800-283-7546
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 175752724
Catalogue (58)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BEYOND SEVEN® CROWN® Condoms | 20003 | FDA UDI | Class II | Active |
| Wink X-Large | 81024 | FDA UDI | Class II | Active |
| CROWN® ASSORTED COLORS Condoms | 31000 | FDA UDI | Class II | Active |
| Wink Closer | 14010 | FDA UDI | Class II | Active |
| 004® ZERO ZERO FOUR® Aloe Condoms | 05003 | FDA UDI | Class II | Unknown |
| BEYOND SEVEN® CROWN® Condoms | 20036 | FDA UDI | Class II | Active |
| Wink Slider | 15003 | FDA UDI | Class II | Active |
| BEYOND SEVEN® MEGA BIG BOY Condoms | 88000 | FDA UDI | Class II | Active |
| Wink Slider | 15010 | FDA UDI | Class II | Active |
| Beyond BodiHeat® | 74910 | FDA UDI | Class I | Active |
| Beyond BodiHeat® | 74988 | FDA UDI | Class I | Active |
| 004® Zero Zero Four® Condoms | 04036 | FDA UDI | Class II | Unknown |
| Wink Closer | 14003 | FDA UDI | Class II | Active |
| 004® ZERO ZERO FOUR® Condoms | 04010 | FDA UDI | Class II | Unknown |
| 004® ZERO ZERO FOUR® Aloe Condoms | 05024 | FDA UDI | Class II | Unknown |
| BEYOND SEVEN ® ALOE ENRICHED Condoms | 41012 | FDA UDI | Class II | Unknown |
| BEYOND SEVEN® MEGA BIG BOY Condoms | 88003 | FDA UDI | Class II | Active |
| BEYOND SEVEN® CROWN® Condoms | 20412 | FDA UDI | Class II | Active |
| Beyond BodiHeat® | 74983 | FDA UDI | Class I | Active |
| 004® ZERO ZERO FOUR® Condoms | 04003 | FDA UDI | Class II | Unknown |
| 004® ZERO ZERO FOUR® Condoms | 04001 | FDA UDI | Class II | Unknown |
| Wink Studded | 51024 | FDA UDI | Class II | Active |
| BEYOND SEVEN® MEGA BIG BOY Condoms | 88012 | FDA UDI | Class II | Active |
| 004® ZERO ZERO FOUR® Aloe Condoms | 05010 | FDA UDI | Class II | Unknown |
| BEYOND SEVEN® ULTRA THIN Condoms | 70012 | FDA UDI | Class II | Active |
| Wink Closer | 14024 | FDA UDI | Class II | Active |
| BEYOND SEVEN® CROWN® Condoms | 20100 | FDA UDI | Class II | Active |
| BEYOND SEVEN® ALOE ENRICHED Condoms | 41000 | FDA UDI | Class II | Unknown |
| BEYOND SEVEN® ULTRA THIN Condoms | 71000 | FDA UDI | Class II | Active |
| Wink Studded | 51010 | FDA UDI | Class II | Active |
| Wink Closer | 14001 | FDA UDI | Class II | Active |
| Wink X-Large | 81010 | FDA UDI | Class II | Active |
| 004® ZERO ZERO FOUR® Condoms | 04024 | FDA UDI | Class II | Active |
| CROWN® Condoms | 21000 | FDA UDI | Class II | Active |
| Wink X-Large | 81003 | FDA UDI | Class II | Active |
| Wink Closer | 14998 | FDA UDI | Class II | Active |
| Beyond BodiHeat® | 74982 | FDA UDI | Class I | Active |
| BEYOND SEVEN® Studded Condoms | 52012 | FDA UDI | Class II | Active |
| BEYOND SEVEN® Studded Condoms | 51000 | FDA UDI | Class II | Active |
| BEYOND SEVEN® ULTRA THIN Condoms | 70003 | FDA UDI | Class II | Active |
| Wink Studded | 51003 | FDA UDI | Class II | Active |
| Wink Slider | 15024 | FDA UDI | Class II | Active |
| Beyond BodiHeat® | 74984 | FDA UDI | Class I | Active |
| Male Latex Condom HA | K252622 | FDA 510(k) | Class II | Active |
| Okamoto Ultra Thin | K090259 | FDA 510(k) | Class II | Active |
| Rubber Contraceptive, Latex Condoms | K875111 | FDA 510(k) | Class II | Active |
| 0.04 ZERO ZERO FOUR Male Latex Condom | K243584 | FDA 510(k) | Class II | Active |
| Mega Big Boy Condom | K140379 | FDA 510(k) | Class II | Active |
| Skinless-Skin, Pink Tint (condom) | K872812 | FDA 510(k) | Class II | Active |
| Skinless Skin-Harmony Condoms | K872664 | FDA 510(k) | Class II | Active |
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