Data / Medical devices / China / Jiale Health Technology Shenzhen Co., Ltd.
Jiale Health Technology Shenzhen Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Jiale Health Technology Shenzhen Co., Ltd. is registered with the FDA (registration 3031238386) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031238386
- Address
- 201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China, Shenzhen Guangdong, China, 518000
- Owner or operator
- Jiale Health Technology Shenzhen Co., Ltd. (10090635)
- Roles
- Manufacturer
- First device listed
- April 22, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| March 17, 2025 | K242140 | Air Compression Leg Massager (K-705) | IRP | Substantially Equivalent | Jiale Health Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Powered Inflatable Tube
- All makers of Vibrator, Therapeutic
- All makers of Massager, Therapeutic, Electric
Updated March 17, 2025. 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.