Data / Medical devices / United States / Harmony Health Tech Inc
Harmony Health Tech Inc: FDA-registered device maker in Brooklyn, NY, United States, 6 510(k) clearances
Harmony Health Tech Inc is registered with the FDA (registration 3037609256) in Brooklyn, NY, United States. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037609256
- Address
- 1414 Sheepshead Bay Rd Ste 102, Brooklyn, NY, United States, 11235
- Owner or operator
- Harmony Health Tech Inc (10093795)
- Roles
- Repackager or relabeler
- First device listed
- July 23, 2025
- Registered through
- 2026
- Brand names listed
- Bone Regrowth Stimulator; STIMULATOR, NERVE TRANSCUTANEOUS.OVER.THE-COUNTER ,FM-B2501,FM-B2503, Cold Compression Therapy System, Durable Medical Equipment (DME), Cold Compression Therapy System, Infrared Mat, PEMF Mat, Massage gun, Jet Spa, Orthopaedic Car Seat, Seating system, PLT Laser Device, Segments Pneumatic Equipment Compression Device and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2026 | K253919 | Cryo And Thermo Therapy System | IRP | Substantially Equivalent | Xiamen Weiyou Intelligent Technology Co., Ltd. | accessdata.fda.gov |
| July 19, 2024 | K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| January 19, 2024 | K230524 | Cold Compression Wrap Pro | IRP | Substantially Equivalent | Chengdu Cryo-Push Medical Technology Co.,Ltd | accessdata.fda.gov |
| May 9, 2023 | K223825 | Tens & Ems Device | NUH | Substantially Equivalent | Shenzhen Jian Feng Electronic Technology Co., Ltd. | accessdata.fda.gov |
| March 8, 2023 | K222098 | ManaSport+ | IMI | Substantially Equivalent | Manamed, Inc. | accessdata.fda.gov |
| May 11, 2021 | K210967 | Air Pressure Therapy System: VU-IPC06 | IRP | Substantially Equivalent | Xiamen Weiyou Intelligent Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
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- All makers of Stimulator, Muscle, Powered
Updated June 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.