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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution

  • B786SBM1AA1100 ()
SBM1AA110

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • B786SBM1AA0170 ()
SBM1AA017

  • Analgesic transcutaneous electrical nerve stimulation system
(12"-14") Royal Stretch 3 Ply Wool/Silver Medium No Hole
Royal Knit, Inc.
XRS3-1/2-14
In Commercial Distribution

  • G296XRS312140 ()
XRS3-1/2-14

  • Stump sock
(10"-12") Royal Stretch 3 Ply Wool/Silver Medium No Hole
Royal Knit, Inc.
XRS3-1/2-12
In Commercial Distribution

  • G296XRS312120 ()
XRS3-1/2-12

  • Stump sock
(12"-14") Royal Stretch 3 Ply Wool/Silver Small No Hole
Royal Knit, Inc.
XRS3-0/1-14
In Commercial Distribution

  • G296XRS301140 ()
XRS3-0/1-14

  • Stump sock
(10"-12") Royal Stretch 3 Ply Wool/Silver Small No Hole
Royal Knit, Inc.
XRS3-0/1-12
In Commercial Distribution

  • G296XRS301120 ()
XRS3-0/1-12

  • Stump sock
(8"-10") Royal Stretch 3 Ply Wool/Silver Small No Hole
Royal Knit, Inc.
XRS3-0/1-10
In Commercial Distribution

  • G296XRS301100 ()
XRS3-0/1-10

  • Stump sock
(16"-20") Royal Brace Sock 2 Ply Silver X-Large Closed Toe
Royal Knit, Inc.
XROBS-35-16
In Commercial Distribution

  • G296XROBS35160 ()
XROBS-35-16

  • Stump sock
(22"-28") Royal Brace Sock 2 Ply Silver Large Closed Toe
Royal Knit, Inc.
XROBS-23-20
In Commercial Distribution

  • G296XROBS23200 ()
XROBS-23-20

  • Stump sock
(16"-20") Royal Brace Sock 2 Ply Silver Large Closed Toe
Royal Knit, Inc.
XROBS-23-16
In Commercial Distribution

  • G296XROBS23160 ()
XROBS-23-16

  • Stump sock
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