Data / Medical devices / Hong Kong / Direcsource Limited
Direcsource Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance
Direcsource Limited is registered with the FDA (registration 3016964847) in Hong Kong, Hong Kong. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016964847
- Address
- Flat/Rm A, 12/F, ZJ 300, 300 Lockhart Road, Wan Chai, Hong Kong, Hong Kong, 999077
- Owner or operator
- DIRECSOURCE LIMITED (10084990)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- April 26, 2022
- Registered through
- 2026
- Brand names listed
- COLLAR, Donjoy, Procare
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Traction | ILZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Exporter to the US | accessdata.fda.gov |
| Insoles, Medical | KYS | 1 | Contract manufacturer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Contract manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| February 6, 2019 | K181981 | CO2 Sampling Line | CCK | Substantially Equivalent | Tylenol Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Limb Brace
- All makers of Mask, Oxygen
- All makers of Accessories, Traction
- All makers of Orthosis, Cervical
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Protector, Skin Pressure
Updated February 6, 2019. 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.