Apex®M by Viveve

Basic Information

• Brand Name: Apex®M by Viveve
• Primary DI: 00851508007097
• Version / Model: 3100000A4
• Catalog Number: 3100000A4
• Company Name: INCONTROL MEDICAL, LLC
• Labeler DUNS: 052247990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-28
• Public Version: 4
• Public Version Date: 2019-03-20
• Public Version Status: Update
• Public Device Record Key: e7fe78d8-9a96-4598-9589-401e1334bd66

Device Description

ApexM by Viveve

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPI	STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE	Gastroenterology, Urology	876.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46624	Pelvic floor muscle exerciser	A manual device used by women to provide Kegel exercise (alternate contraction and relaxation of perineal muscles) to treat urinary stress incontinence, sexual dysfunction, or to tone the muscles of the pelvic floor. It is typically inserted into the vagina and is available in a variety of designs that commonly includes a spring-loaded, split, cantilevered cylinder that requires the voluntary contraction of the vagina to squeeze it together, or a solid metal, profiled weight that is gripped by the vaginal muscles as gravity pulls it downward. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851508007097	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150183	000

Device Sizes

Type	Value	Unit	Text
Length	12	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 54 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity