Exer Health

GUDID G186EXERHEALTH20

Exer Labs, Inc.

Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software
Primary Device IDG186EXERHEALTH20
NIH Device Record Key3d6ee530-b1ab-4ae4-b49d-3f30618fb790
Commercial Distribution StatusIn Commercial Distribution
Brand NameExer Health
Version Model Number2
Company DUNS069864301
Company NameExer Labs, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG186EXERHEALTH20 [Primary]

FDA Product Code

QKCInteractive Rehabilitation Exercise Device, Prescription Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-29
Device Publish Date2023-03-21

Devices Manufactured by Exer Labs, Inc.

G186EXERHEALTH20 - Exer Health2023-03-29
G186EXERHEALTH20 - Exer Health2023-03-29
G186EXERGAIT10 - Exer Gait2022-05-30
G186EXERPHYSIO20 - Exer Physio2022-01-12

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