Curapuls 670

Q: When was Curapuls 670 cleared by the FDA?

Curapuls 670 (K243112) received a 510(k) decision of Substantially Equivalent on June 25, 2025, 268 days after the submission was received.

Q: What is the product code of K243112?

The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.

FDA 510(k) K243112 · Enraf-Nonius, B.V.

Substantially Equivalent

510(k) numberK243112

Submission

Device name: Curapuls 670
Applicant: Enraf-Nonius, B.V.
Rotterdam, NL
Received: September 30, 2024
Decision date: June 25, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.5290
Specialty: Physical Medicine

Other 510(k)s with product code IMJ

510(k)	Device	Applicant	Decision
K252963	BTL-899TTIMJ · Traditional	BTL Industries, Inc.	06/12/2026SE
K250376	ViVYIMJ · Traditional	Viatherm Therapeutics, LLC	11/05/2025SE
K223620	Reprieve by RegenesisTMIMJ · Traditional	Regenesis Biomedical, Inc.	05/24/2023SE
K182363	BTL-703IMJ · Traditional	BTL Industries, Inc.	01/24/2019SE
K173300	ViaTherm BOOSTIMJ · Traditional	Viatherm Therapeutics, LLC	05/01/2018SE
K162240	ProMedTek Model C1400 Shortwave Diathermy DeviceIMJ · Traditional	Promedtek, Inc.	11/17/2016SE
K161862	ThermoProIMJ · Traditional	Zimmer Medizinsysteme GmbH	11/14/2016SE
K153456	Megapulse III Shortwave DiathermyIMJ · Traditional	Accelerated Care Plus	06/14/2016SE
K131926	ThermopulseIMJ · Traditional	Ibramed Equipamentos Medicos	07/24/2014SE
K131899	Sw-ThermIMJ · Traditional	Shenzhen Dongdixin Technology Co., Ltd.	03/14/2014SE

More from Shenzhen Dongdixin Technology Co., Ltd.

510(k)	Device	Decision
K251083	Compact IIIPF · Traditional	09/12/2025SE
K230472	Sonopuls 190IMI · Traditional	10/24/2023SE
K151640	Eltrac 471ITH · Traditional	10/16/2015SE
K030297	Flexible Rubber Electrodes, Models: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130GXY · Traditional	04/28/2003SE

Questions and answers

When was Curapuls 670 cleared by the FDA?

Curapuls 670 (K243112) received a 510(k) decision of Substantially Equivalent on June 25, 2025, 268 days after the submission was received.

What is the product code of K243112?

The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.