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Bioness, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K211965 StimRouter Neuromodulation SystemGZF2022-02-23 View
510(k) K200482 StimRouter Neuromodulation SystemGZF2020-03-27 View
510(k) K200262 L100 Go SystemGZI2020-03-04 View
510(k) K190047 StimRouter Neuromodulation SystemGZF2019-10-31 View
510(k) K191587 L360 Thigh SystemGZI2019-09-12 View
510(k) K190285 L300 Go SystemGZI2019-03-14 View
510(k) K173682 L300 Go SystemGZI2018-03-09 View
510(k) K162407 L300 Go SystemGZI2017-01-27 View
510(k) K123636 H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICEGZI2013-05-01 View
510(k) K122784 NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHTGZI2012-12-27 View
510(k) K120853 NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,GZI2012-04-20 View
510(k) K103343 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)GZI2011-04-29 View
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