ReGrasp

GUDID 17540176030079

ReGrasp Electrode Set

Rehabtronics Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID17540176030079
NIH Device Record Key41fdd545-0429-4b59-b739-168fea5a63ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameReGrasp
Version Model NumberHSE1
Company DUNS243936569
Company NameRehabtronics Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117540176030079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2017-08-29

On-Brand Devices [ReGrasp]

17540176030109ReGrasp Replacement Wrist-Support
17540176030093ReGrasp Clinician System Refill
17540176030086ReGrasp Clinician System
17540176030079ReGrasp Electrode Set
17540176030062ReGrasp Replacement Garment (Large Size)
17540176030055ReGrasp Replacement Garment (Medium Size)
17540176030048ReGrasp Replacement Garment (Small Size)
17540176030000ReGrasp Personal System
17540176030116ReGrasp Base System
17540176030130ReGrasp Electrode Positioning Kit Refill
17540176030123ReGrasp Electrode Positioning Kit
17540176030253EPKV2 Dock Assembly
17540176030246EPK Cotton Electrodes (Small)
17540176030239EPK Cotton Electrodes (Large)
17540176030222EPK Small Gel Electrodes
17540176030215EPK Large Gel Electrodes
17540176030208EPK Pens
17540176030192EPK Transfer Sheet
17540176030185ReGrasp Garment Liners (large)
17540176030178ReGrasp Garment Liners (medium)
17540176030161ReGrasp Garment Liners (small)
17540176030154ReGrasp HMS Button Control
17540176030147ReGrasp Electrode Positioning Kit Version 2

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