FDA.reportPublic FDA data

INNOVO

Primary DI
15391533470548
Brand
INNOVO
Company
ATLANTIC THERAPEUTICS LIMITED
Model
208
Catalog number
1500-0821
Device description
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
Published
2021-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QAJCutaneous Electrode Stimulator For Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAJCutaneous Electrode Stimulator For Urinary IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170049000
K192357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170049000InnovoBio-Medical Research, Ltd.2018-11-06QAJ
K192357000INNOVOAtlantic Therapeutics, Ltd.2020-01-16QAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391533470548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1539153347054815391533470548

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985573648
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15391533470500INNOVO2081500-08172021-05-11
15391533470517INNOVO2081500-08182021-05-11
15391533470524INNOVO2081500-08192021-05-11
15391533470531INNOVO2081500-08202021-05-11
15391533470555INNOVO2081500-08222021-05-11
15391533470562INNOVO2081500-08232021-05-11
15391533470579INNOVO2081500-08242021-05-11
15391533470586INNOVO2081500-08252021-05-11
15391533470913INNOVO2080208-50332021-05-11
15391533470920INNOVO2080208-50342021-05-11
15391533470937INNOVO2080208-50352021-05-11
15391533470944INNOVO2080208-50362021-05-11
15391533470951INNOVO2080208-50372021-05-11
15391533470968INNOVO2080208-50382021-05-11
15391533470975INNOVO2080208-50392021-05-11
15391533470982INNOVO2080208-50402021-05-11
15391533471101INNOVO2080208-50322021-05-11
15391533471118INNOVO2080209-50022021-05-11
15391533471125INNOVO2080209-50032021-05-11
15391533471132INNOVO2080209-50042021-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851096008049Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008155Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008162Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008131ElitoneElidah, Inc.QAJ2026-02-18
00851096008148Elitone URGEElidah, Inc.QAJ2026-02-18
00851096008179ElitoneElidah, Inc.QAJ2026-02-18
00851096008186Elitone URGEElidah, Inc.QAJ2026-02-18
00851096008056ElitoneElidah, Inc.QAJ2024-12-19
00851096008117Elitone URGEElidah, Inc.QAJ2024-12-19
00851096008100ELITONE URGEElidah, Inc.QAJ2023-04-13
15391533470500INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470517INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470524INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470531INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470555INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470562INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470579INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470586INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470913INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470920INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470937INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470944INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470951INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470968INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470975INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470982INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471101INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471118INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471125INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471132INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11