Apex®M

FDA UDI

Class II (US FDA UDI)

by Incontrol Medical, Llc

Identity

Trade Name: Apex®M FDA UDI
Generic Name: Pelvic floor muscle exerciser FDA UDI
Device Name: ApexM FDA UDI
Model / Reference: 3100000A1 FDA UDI
Description: ApexM FDA UDI

Identifiers

Catalog Number: 3100000A1 FDA UDI
Primary DI / UDI-DI: 00851508007035 FDA UDI
510(k) Number: K150183 FDA UDI
FDA Product Code: KPI FDA UDI
GMDN Term: Pelvic floor muscle exerciser FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 12 Inch FDA UDI

Category: Pelvic floor muscle exerciser

Apex®M by Incontrol Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K150183 also covers:

Apex®M by Viveve — INCONTROL MEDICAL, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Incontrol Medical, Llc

Sources (1)

FDA UDI 8bdccfac-4669-4e63-b8d6-61bc14df1257 38 fields · synced May 30, 2026