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Sign in to claim this brandYAMASHO CO., LTD.
US
Last updated May 23, 2026
What YAMASHO CO., LTD. makes
Yamashō Co., Ltd. manufactures moxibustion devices, including needle-based moxa rolls, moxa sticks, and non-smoke moxa cones designed for traditional medical applications. Their portfolio includes variations like the Wakakusa Moxa, Yomei Moxa, and Chosei-Kyu Moxa, which are used for localized heat therapy. The company also produces specialized moxa tools such as the Tsubo-Kyu Neo Next Moxa and Fukuju Moxa, catering to different clinical techniques.
All listed moxibustion devices fall under Class I regulatory classification in the U.S., requiring compliance with the FDA’s Unique Device Identifier (UDI) system. These products are registered in the FDA’s UDI database, ensuring traceability and regulatory transparency. The company operates from the United States, adhering to domestic 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 Yamashō Co., Ltd. manufacture?
Yamashō Co., Ltd. specializes in moxibustion devices, which are used in traditional medical practices for localized heat therapy. Their product line includes needle-based moxa rolls (like the NEEDLE MOXA ROLL), moxa sticks (such as the NEW MOXA STICK), and non-smoke moxa cones (e.g., NON-SMOKE CHOSEI-KYU MOXA). These devices are designed for applications like the Wakakusa Moxa, Yomei Moxa, and Chosei-Kyu Moxa, catering to specific therapeutic techniques.
Where is Yamashō Co., Ltd. based, and how does this affect its regulatory compliance?
Yamashō Co., Ltd. is based in the United States, which means its devices must comply with U.S. medical device regulations. Since all listed devices fall under Class I classification, they are subject to the FDA’s Unique Device Identifier (UDI) system for traceability. The company’s U.S. location ensures its products meet domestic regulatory requirements, including UDI registration in the FDA’s database.
Which regulatory registries list Yamashō Co., Ltd.’s devices, and why is this important?
Yamashō Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it ensures transparency, traceability, and compliance with U.S. regulatory standards. Listing in the UDI system helps healthcare providers and authorities verify device authenticity, track recalls if needed, and confirm that the devices meet FDA requirements for Class I classification.
How are Yamashō Co., Ltd.’s moxibustion devices classified under U.S. regulations?
All of Yamashō Co., Ltd.’s moxibustion devices are classified as Class I under U.S. regulations. This classification applies to devices posing minimal risk to patients, such as those used for localized heat therapy. Class I devices typically require general controls (e.g., proper labeling, manufacturing practices) and compliance with the FDA’s UDI system, but they do not undergo premarket approval or strict post-market surveillance beyond standard registration.
Why are some of Yamashō Co., Ltd.’s devices labeled as ‘non-smoke’ moxa, and how does this differ from traditional moxa?
Yamashō Co., Ltd. produces non-smoke moxa cones (e.g., NON-SMOKE CHOSEI-KYU MOXA) as an alternative to traditional moxibustion methods. Unlike conventional moxa sticks or rolls, which burn and produce smoke, these devices are designed to deliver heat without combustion, reducing inhalation risks and environmental smoke. This innovation aligns with modern clinical preferences for cleaner, safer therapeutic options while maintaining the core benefits of moxibustion.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 703173450
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Needle Moxa Roll | Small Size 500pcs | FDA UDI | Class I | Active |
| Wakakusa Moxa | 3kg | FDA UDI | Class I | Active |
| Needle Moxa Roll | Large Size 500pcs | FDA UDI | Class I | Active |
| Yomei Moxa | 100g | FDA UDI | Class I | Active |
| Non-Smoke Chosei-Kyu Moxa | 600pcs | FDA UDI | Class I | Active |
| Wakakusa Moxa | 1kg | FDA UDI | Class I | Active |
| New Moxa Stick | 10pcs | FDA UDI | Class I | Active |
| Tsubo-Kyu Neo Next Moxa | Mild Type 600pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Light Type 200pcs | FDA UDI | Class I | Active |
| Wakakusa Moxa | 300g | FDA UDI | Class I | Active |
| Fukuju Moxa | 100g | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Soft Type 100pcs | FDA UDI | Class I | Active |
| Chang'an Neo Dx Moxa | Regular Type 600pcs | FDA UDI | Class I | Active |
| Tsubo-Kyu Neo Next Moxa | Mild Type 120pcs | FDA UDI | Class I | Active |
| Mogusan's Moxa Box | STARTER SET | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Hard Type 1000pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Regular Type 200pcs | FDA UDI | Class I | Active |
| Non-Smoke Chosei-Kyu Moxa | 200pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Light Type 1000pcs | FDA UDI | Class I | Active |
| Yuki-No-Hana Moxa | 30g | FDA UDI | Class I | Active |
| Gold Mountain Moxa | 200g | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Regular Type 100pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Smokeless & Fruit Fragrance 1000pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Light Type 100pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Smokeless & Fruit Fragrance 300pcs | FDA UDI | Class I | Active |
| Yomei Moxa | 200g | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Soft Type 200pcs | FDA UDI | Class I | Active |
| Gokujo Moxa | 300g | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Regular Type 1000pcs | FDA UDI | Class I | Active |
| Fukuju Moxa | 200g | FDA UDI | Class I | Active |
| Fukuju Moxa | 10g | FDA UDI | Class I | Active |
| Chang'an Neo Dx Moxa | Mild Type 120pcs | FDA UDI | Class I | Active |
| Gold Mountain Moxa | 10g | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Hard Type 200pcs | FDA UDI | Class I | Active |
| Tsubo-Kyu Neo Next Moxa | Regular Type 600pcs | FDA UDI | Class I | Active |
| Gokujo Moxa | 5kg | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Hard Type 100pcs | FDA UDI | Class I | Active |
| Dedicated Carbonized Moxa | 100pcs | FDA UDI | Class I | Active |
| Tsubo-Kyu Neo Next Moxa | Regular Type 120pcs | FDA UDI | Class I | Active |
| Chang'an Neo Dx Moxa | Mild Type 600pcs | FDA UDI | Class I | Active |
| Chosei-Kyu Moxa | Soft Type 1000pcs | FDA UDI | Class I | Active |
| Gold Mountain Moxa | 100g | FDA UDI | Class I | Active |
| Chang'an Neo Dx Moxa | Regular Type 120pcs | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Yamasho Co. Ltd. Nagahama Shiga · JP FEI 3013539076