510(k) K183074
K183074 is an FDA 510(k) premarket notification submitted by Astek Technology , Ltd. for the device "TENS and EMS Stimulator, TENS Stimulator". The FDA issued a decision of Substantially Equivalent on Jan 11, 2020. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2020
- Date Received
- Nov 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)