MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003
FDA 510(k) K093138 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK093138
Submission
- Device name
- MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, Guangdong, CN - Received
- October 5, 2009
- Decision date
- February 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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Questions and answers
When was MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003 cleared by the FDA?
MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003 (K093138) received a 510(k) decision of Substantially Equivalent on February 12, 2010, 130 days after the submission was received.
What is the product code of K093138?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.