Strong Medical, Inc.
GR Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Water Irrigator, W1 200 Ref K941325
What Strong Medical, Inc. makes
Strong Medical, Inc. manufactures the W1 200, a water irrigator designed for medical irrigation procedures.
The W1 200 is classified as a Class I device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Strong Medical, Inc. manufacture?
Strong Medical, Inc. specializes in the W1 200, a water irrigator. This device is specifically designed for medical irrigation procedures, ensuring precise fluid delivery during clinical applications.
Where is Strong Medical, Inc. based?
Strong Medical, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices.
How are Strong Medical, Inc.’s devices classified under U.S. regulations?
The W1 200 water irrigator is classified as a Class I device. This classification is typically assigned to devices posing minimal risk to patients, often requiring less stringent regulatory oversight.
Which regulatory registries or databases list Strong Medical, Inc.’s devices?
The W1 200 is listed under the FDA’s 510(k) pathway, meaning it has been evaluated for substantial equivalence to a predicate device. This pathway is used for devices that do not require a full premarket approval process.
Information
- Country
- GR