What is FDA product code NHN?

A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.

Physical Medicine › TherapeuticPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Therapy EC (FDA)

Name: Therapy EC (FDA)
Brand: Therapy EC (FDA)

Therapy EC is a non-heating infrared laser used by healthcare professionals as an adjunct for temporary relief of hand and wrist pain associated with carpal tunnel syndrome. An 808 nm diode…

Registry build 21.09.26

Therapy EC is a non-heating infrared laser used by healthcare professionals as an adjunct for temporary relief of hand and wrist pain associated with carpal tunnel syndrome. An 808 nm diode generates the light delivered toward the treatment area.

Electrical current through the diode controls its optical output, and optical fibers conduct the light. A polycarbonate spacer sets the distance between the treatment tip and the skin. This spacer is the only part of the device that contacts the patient.

Equipment Components

The system includes a handpiece, handpiece holder, battery, charging cable and transport case. Protective glasses and an eye protector are also included with the equipment.

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Hubei (4), Guangdong (1).

Chinese manufacturers registered for FDA product code NHN
Manufacturer	City	Province	Registered as	Device types
Hubei YJT Intelligent Technology Group Co., Ltd.	Wuhan	Hubei	Contract manufacturer	12
Rhein Laser Technologies Co., Ltd.	Wuhan	Hubei	Complaint-file establishment	6
Wuhan Lotuxs Technology Co., Ltd.	Wuhan	Hubei	Complaint-file establishment	5
Wuhan Guangdun Technology Co., Ltd.	Wuhan	Hubei	Manufacturer	2
Seic Shenzhen Shinelong Electronics Industrial Co.	Long Gang District,, Shenzhen	Guangdong	Contract manufacturer	1

Record

Regulatory record for Therapy EC (FDA)
Listed by	DMC Importacao E Exportacao DE Equipamentos Ltda, Brazil
FDA product code	NHN
Device type	Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Device class	Class 2
Regulation	21 CFR 890.5500
Establishment	Manufacturer
510(k)	K232813
Record published	2025-01-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Therapy EC (FDA)
Catalogue number	Size	Status
980030032		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ML 830®	Microlight Corporation OF America	24
LEP 2000 Photonic Therapy System	IMI Healing Technologies Inc	6
FX635	Erchonia Corporation	2
Theralase	Theralase Technologies Inc.	2
Collagentex Series	Tanses Technologies, Inc.	2
Laspot	Wuhan Guangdun Technology Co., Ltd.	1
EVL	Erchonia Corporation	1
PL Touch	Erchonia Corporation	1
Erchonia GVL	Erchonia Corporation	1
Therapy XT (FDA)	DMC Importacao E Exportacao DE Equipamentos Ltda	1
GlobTek	Microlight Corporation OF America	1
Therapy US (FDA)	DMC Importacao E Exportacao DE Equipamentos Ltda	1

Showing 12 of 18. All products under Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232813	2024-12-19

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.