FDA.reportPublic FDA data

INNOVO

Primary DI
15391533470418
Brand
INNOVO
Company
ATLANTIC THERAPEUTICS LIMITED
Model
208
Catalog number
0208-5006
Device description
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
Published
2019-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170049000InnovoBio-Medical Research, Ltd.2018-11-06QAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391533470418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1539153347041815391533470418

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985573648
Device count
1
Lot or batch
true
Serial number
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
15391533470548INNOVO2081500-08212021-05-11
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

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
15391533470548INNOVOATLANTIC 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