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510(k) K202648

Biofeedback Nerve and Muscle Stimulator by Shenzhen Konmed Technology Co., Ltd. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2020
Date Received
September 11, 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

Other clearances by Shenzhen Konmed Technology Co., Ltd.

  • K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 (February 23, 2024)
  • K220161 — Biofeedback Nerve and Muscle Stimulator (July 20, 2022)
  • K163288 — Pelvifine Pelvic Muscle Trainer (January 18, 2018)
  • K171722 — Electrodes with snap / Electrodes with pigtail (January 10, 2018)
  • K171721 — Electrodes with silver conductive (January 5, 2018)

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