FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator
FDA 510(k) K113010 · Famidoc Technology Co., Ltd.
510(k) numberK113010
Submission
- Device name
- FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator
- Applicant
- Famidoc Technology Co., Ltd.
Shenzhen, CN - Received
- October 11, 2011
- Decision date
- December 21, 2012
- 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 FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator cleared by the FDA?
FDES100(TENS and EMS Stimulator, FDES102(ED402) TENS Stimulator (K113010) received a 510(k) decision of Substantially Equivalent on December 21, 2012, 437 days after the submission was received.
What is the product code of K113010?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.