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510(k) K771765

MYO-CHECK by Med General — Product Code BXN

K771765 is an FDA 510(k) premarket notification submitted by Med General for the device "MYO-CHECK". The FDA issued a decision of Substantially Equivalent on September 30, 1977. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Med General has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1977
Date Received
September 19, 1977
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 Med General

  • K791097 — CEPTORTRODE WITH CEPTOR HESIVE (August 3, 1979)
  • K791098 — SINGLE-USE MINI-BULLDOG (June 22, 1979)
  • K790763 — MAXI-VAC TM (April 23, 1979)
  • K790269 — CEPTOR HESIVE (February 26, 1979)
  • K782006 — MEDGENERAL SINGLE-USE BULLDOG (December 15, 1978)
  • K781239 — MYO-STIM (November 3, 1978)
  • K780632 — MAXICEPTOR (August 14, 1978)
  • K780698 — STIMULATORS, NERVE, ELECTRICAL (May 12, 1978)
  • K780117 — CARDIOMETER (February 3, 1978)
  • K771702 — VESSEL-STABILIZER (December 13, 1977)

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)
  • 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)

FDA data resources