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510(k) K202110

MStim Drop Model: LGT-233 by Guangzhou Longest Science & Technology Co., Ltd. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2021
Date Received
July 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

Other clearances by Guangzhou Longest Science & Technology Co., Ltd.

  • K201845 — Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) (October 8, 2020)
  • K182020 — Portable Electro-Stimulation Therapy Device (September 17, 2020)
  • K191856 — Compression Therapy Device (March 19, 2020)
  • K191862 — Compression Therapy Device Model LGT-2200SP (October 29, 2019)
  • K182108 — Portable Electro-Stimulation Therapy Device (April 26, 2019)

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