Data / Medical devices / China / Dikaku Industrial Co.,limited
Dikaku Industrial Co.,limited: FDA-registered device maker in Hong Kong, China, 3 510(k) clearances
Dikaku Industrial Co.,limited is registered with the FDA (registration 3023876581) in Hong Kong, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 3, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3023876581
- Address
- Flat/Rm 7022 BLK D 7/F Tak, Wing Industry BLDG 3 Tsun Wen, Road Tuen Mun NT, Hong Kong, China, 999077
- Owner or operator
- DIKAKU INDUSTRIAL CO.,LIMITED (10085727)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- July 26, 2022
- Registered through
- 2026
- Brand names listed
- 2-IN-1 COLD & HEAT THERAPY MACHINE (Model: CH600), 2-in-1 Nasal Aspirator With Sprayer (Model: YEBX-01), Cosyish Baby Nasal Aspirator, FR-A1, FR-A2, FR-A3, FR-A4, FR-A5, FR-A6, FR-A7, FR-B1, FR-B2, FR-B3, FR-B4, FR-B5, FR-B6, FR-B7, FR-F1, FR-F2, FR-F3,, FR-F4, FR-F5, FR-F6, FR-F7, FR-H1, FR-H2, FR-H3, FR-H4, FR-H5, FR-H6, FR-H7, HOT/COLD PACK (Model: Navy), HY-A1, HY-A2, HY-A3, HY-A4, HY-A5, HY-A6, HY-A7, HY-A8, HY-A9, HY-B1, HY-B2, HY-B3, HY-B4, HY-B5, HY-B6, HY-B7, HY-B8,, HY-B9, HY-F1, HY-F2, HY-F3, HY-F4, HY-F5, HY-F6, HY-F7, HY-F8, HY-F9 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Foreign private label distributor | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| June 3, 2020 | K200929 | Hair Growth System | OAP | Substantially Equivalent | Xuzhou Kernel Medical Equipment Co., Ltd. | accessdata.fda.gov |
| December 13, 2019 | K192627 | Laser Hair Growth Cap | OAP | Substantially Equivalent | Shang FA Biotechnology Co. | accessdata.fda.gov |
| July 26, 2019 | K190685 | Hair Growth System | OAP | Substantially Equivalent | Xuzhou Kernel Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Nasal Spray, Ent Delivery
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Laser, Comb, Hair
- All makers of Bottle, Collection, Vacuum
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated June 3, 2020. 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.