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510(k) K162479

Smart Pain Reliever, Model LT5019 by Shenzhen Dongdixin Technology Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2017
Date Received
September 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Shenzhen Dongdixin Technology Co., Ltd.

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  • K180331 — Wireless Pain Relieve Device (June 22, 2018)
  • K171430 — Incontinence Treatment Device, Model LT2061 (March 15, 2018)
  • K173462 — Wireless Pain Relieve Device Model: LT5018C (December 8, 2017)
  • K171978 — Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (October 2, 2017)
  • K161735 — Non-contact Forehead Thermometer (November 17, 2016)
  • K150436 — ComboRehab (November 13, 2015)
  • K142976 — UltraTENS (August 26, 2015)

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  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)