Home / 510(k) Clearances / K153045

510(k) K153045

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator by Easy Med Instrument Co., Ltd. — Product Code BXN

K153045 is an FDA 510(k) premarket notification submitted by Easy Med Instrument Co., Ltd. for the device "SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator". The FDA issued a decision of Substantially Equivalent on May 13, 2016. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Easy Med Instrument Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2016
Date Received
October 19, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Battery-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Easy Med Instrument Co., Ltd.

  • K143430 — SmartTENS (May 29, 2015)
  • K050921 — EASYSTIM NMS-28 (December 12, 2005)
  • K040253 — EASY MED TN-28 C (April 8, 2004)

Other clearances for product code BXN

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K162086 — MultiStim ECO (January 6, 2017)
  • K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator (March 24, 2015)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K111985 — MYOGUIDE SYSTEM MODEL 8008 (December 30, 2011)
  • K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR (February 17, 2011)
  • K102084 — STIMPOD NMS450 NERVE STIMULATOR (December 16, 2010)
  • K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR (December 3, 2009)
  • K091155 — ASCEND (September 3, 2009)

FDA data resources