Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037609256

FEI Number

3037609256

Entity Name

HARMONY HEALTH TECH INC

City/State/Country

Brooklyn, NY, US

Establishment Address

1414 Sheepshead Bay Rd, Ste 102, Brooklyn, NY 11235, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Harmony Health Tech Inc (Owner Number: 10093795)

Owner / Operator Contact Address

1414 Sheepshead Bay Rd, Ste 102, Brooklyn, NY 11235, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253919

PMA Number

N/A

All Registered Proprietary Names

Transcutaneous Electrical Nerve Stimulator, Joint Stimulator Model SM9116, SM9143 Cold Compression Therapy System water sacculation, cold therapy system Shijiazhuang Aofeite Medical Device Co., Ltd Durable Medical Equipment (DME), Cold Compression Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2025-08-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-08-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-08-20
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-08-20
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2026-01-22
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2026-01-22
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2026-04-02
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-07-23
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2026-06-17
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2026-06-17

Official Correspondent

Marat Babakhanov

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Harmony Health Tech Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

Similar Registrations

Registration Number	Establishment Name	Location
3007661914	AB ELECTRONICS	Danbury, CT, US
3037967280	ALGIAMED TECHNOLOGIES USA INC	Lake Mary, FL, US
3041000312	SYSTEC ENGINEERING, LLC	Euless, TX, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037609256. Last updated year: 2026. Please use registration number 3037609256 when referencing this establishment in official correspondence.