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510(k) K121743

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN by Sunmed, LLC — Product Code BXN

K121743 is an FDA 510(k) premarket notification submitted by Sunmed, LLC for the device "EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN". The FDA issued a decision of Substantially Equivalent on March 28, 2013. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Sunmed, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
June 13, 2012
Clearance Type
Traditional
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 Sunmed, LLC

  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K081805 — CUFFALERT (November 14, 2008)
  • K062112 — SUNMED FOLEY CATHETERS (June 4, 2007)
  • K955631 — ORTHOPLUG HARD BONE DESIGN (February 27, 1996)
  • K955632 — ORTHOPLUG SOFT BONE DESIGN (February 27, 1996)
  • K921263 — SUNLITE LARYNGOSCOPE (June 1, 1993)

Other clearances for product code BXN

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K162086 — MultiStim ECO (January 6, 2017)
  • K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (May 13, 2016)
  • K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator (March 24, 2015)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • 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