510(k) K202031
K202031 is an FDA 510(k) premarket notification submitted by Remed Co., Ltd. for the device "Talent-Pro Electromagnetic Stimulator". The FDA issued a decision of Substantially Equivalent on May 6, 2021. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Remed Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2021
- Date Received
- Jul 22, 2020
- 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)