L300 Go System, Left Thigh Plus

GUDID 00815962020153

L300 Go system with Left Thigh cuff

BIONESS INC.

Gait-enhancement electrical stimulation system, external
Primary Device ID00815962020153
NIH Device Record Key634c9ce9-3b28-455c-ac04-7d044539937f
Commercial Distribution StatusIn Commercial Distribution
Brand NameL300 Go System, Left Thigh Plus
Version Model NumberL4P-5001
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020153 [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 Number4
Public Version Date2019-11-08
Device Publish Date2017-02-14

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