Data / Medical devices / China / Klarity Medical & Equipment (GZ) Co., Ltd.
Klarity Medical & Equipment (GZ) Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 5 510(k) clearances
Klarity Medical & Equipment (GZ) Co., Ltd. is registered with the FDA (registration 3003803149) in Guangzhou Guangdong, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 18, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003803149
- Address
- No. 6, Bihua Street Huangpu District, Guangzhou Guangdong, China, 510730
- Owner or operator
- KLARITY MEDICAL & EQUIPMENT (GZ) CO, LTD. (9050591)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 3, 2006
- Registered through
- 2026
- Brand names listed
- AccuForm Cushions, Contour Blend Splinting Material, Contour Pro Splinting Material, EzeFit¿ Splinting Material, KLARITY BASEPLATES, KLARITY THERMOPLASTIC, KS Splinting Material, Klarity Bolus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Holder, Head, Radiographic | IWY | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer, 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 18, 2025 | K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | IYE | Substantially Equivalent | Klarity Medical & Equipment (GZ) Co., Ltd. | accessdata.fda.gov |
| November 1, 2022 | K220539 | Klarity SRS Baseplate, Klarity Promise Baseplate | IYE | Substantially Equivalent | Klarity Medical & Equipment (GZ) Co., Ltd. | accessdata.fda.gov |
| May 14, 2021 | K202747 | Klarity Bolus | IYE | Substantially Equivalent | Klarity Medical & Equipment (GZ) Co., Ltd. | accessdata.fda.gov |
| November 1, 2013 | K132124 | KLARITY VACUUM BAG, KLARITY MOLD CUSHION | IYE | Substantially Equivalent | Klarity Medical Products, LLC | accessdata.fda.gov |
| November 12, 2002 | K022708 | KLARITY | IYE | Substantially Equivalent | Larson Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Holder, Head, Radiographic
- All makers of Splint, Hand, And Components
Updated March 18, 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.