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510(k) K231440

Combo Electrotherapy Device by Shenzhen Roundwhale Technology Co. , Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2023
Date Received
May 18, 2023
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

Other clearances by Shenzhen Roundwhale Technology Co. , Ltd.

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  • K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt (January 11, 2024)
  • K222252 — Self-adhesive Electrode (January 19, 2023)
  • K192087 — Combo Electrotherapy Device (November 1, 2019)
  • K181688 — R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (September 7, 2018)
  • K180956 — Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimu (June 7, 2018)

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