KEEOGO - CLINICIAN KIT

GUDID 07540162060007

Powered walking assistance device

B-Temia Inc

Programmable ambulation exoskeleton, clinical
Primary Device ID07540162060007
NIH Device Record Keydbff76ef-30b4-43de-b064-8aa12f265086
Commercial Distribution StatusIn Commercial Distribution
Brand NameKEEOGO - CLINICIAN KIT
Version Model Number5062601
Company DUNS244220856
Company NameB-Temia Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com
Phone1 866 443-1010
Emailinfo@b-temia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540162060007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHLPowered Exoskeleton

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-24
Device Publish Date2021-06-16

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