Inwave

Q: When was Inwave cleared by the FDA?

Inwave (K121820) received a 510(k) decision of Substantially Equivalent on August 24, 2012, 64 days after the submission was received.

Q: What is the product code of K121820?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.

FDA 510(k) K121820 · Zynex Medical, Inc.

Substantially Equivalent

510(k) numberK121820

Submission

Device name: Inwave
Applicant: Zynex Medical, Inc.
Lone Tree, CO, US
Received: June 21, 2012
Decision date: August 24, 2012
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KPI – Stimulator, Electrical, Non-Implantable, For Incontinence
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5320
Specialty: Gastroenterology, Urology

Other 510(k)s with product code KPI

510(k)	Device	Applicant	Decision
K260178	Pelvic Muscle Trainer (KM510, KM516B)KPI · Traditional	Shenzhen Konmed Technology Co., Ltd.	06/18/2026SE
K252601	Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…KPI · Traditional	Hunan Accurate Bio-Medical Technology Co., Ltd.	05/14/2026SE
K252552	Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional	Shenzhen Changkun Technology Co., Ltd.	05/06/2026SE
K252831	Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924…KPI · Traditional	Dolanvy (Suzhou) Medical Technology Co., Ltd.	04/28/2026SE
K252334	PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)KPI · Traditional	Pontemedag	04/17/2026SE
K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional	Well-Life Healthcare , Ltd.	02/12/2026SE
K251026	Regenesis EMS ChairKPI · Traditional	Trinity Medical Solutions	08/29/2025SE
K243079	NeuroTrac® MyoPlus Pro (MYO120U)KPI · Traditional	Verity Medical , Ltd.	06/26/2025SE
K241862	Levina Pelvic Floor Muscle Stimulator (RS-48)KPI · Traditional	Zmi Electronics , Ltd.	03/27/2025SE
K241516	BTL-398KPI · Traditional	BTL Industries, Inc.	02/10/2025SE

More from BTL Industries, Inc.

510(k)	Device	Decision
K233485	M-WaveIPF · Abbreviated	01/26/2024SE
K223217	Zynex Monitoring System, Model CM-1600DSB · Traditional	06/16/2023SE
K191697	Cardiac Monitor 1500DSB · Traditional	02/21/2020SE
K111279	Nexwave Combo Muscle Stimulator SystemIPF · Abbreviated	09/20/2011SE

Questions and answers

When was Inwave cleared by the FDA?

Inwave (K121820) received a 510(k) decision of Substantially Equivalent on August 24, 2012, 64 days after the submission was received.

What is the product code of K121820?

The FDA product code is KPI – Stimulator, Electrical, Non-Implantable, For Incontinence, a Class II (moderate risk) device regulated under 21 CFR 876.5320.