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510(k) K111985

MYOGUIDE SYSTEM MODEL 8008 by Intronix Technologies Corp. — Product Code BXN

K111985 is an FDA 510(k) premarket notification submitted by Intronix Technologies Corp. for the device "MYOGUIDE SYSTEM MODEL 8008". The FDA issued a decision of Substantially Equivalent on December 30, 2011. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2011
Date Received
July 12, 2011
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 for product code BXN

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  • 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)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • 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