Data / Medical devices / Taiwan / Acute Ideas Co., Ltd.
Acute Ideas Co., Ltd.: FDA-registered device maker in Taipei, Taiwan, 6 510(k) clearances
Acute Ideas Co., Ltd. is registered with the FDA (registration 3005031124) in Taipei, Taiwan. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005031124
- Address
- 3F, No.11, Lane 35, Jihu Road, Taipei, Taiwan, 114
- Owner or operator
- Acute Ideas Co., Ltd. (10023653)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 7, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US, Repackager or relabeler, Specification developer | 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 12, 2026 | K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | HGX | Substantially Equivalent | A Cute Baby, Inc. | accessdata.fda.gov |
| April 17, 2020 | K200712 | Rumble Tuff Electric Breast Pump | HGX | Substantially Equivalent | A Cute Baby, Inc. | accessdata.fda.gov |
| November 28, 2018 | K180207 | Non-contact Infrared Thermometer | FLL | Substantially Equivalent | Alicn Medical (Shenzhen), Inc. | accessdata.fda.gov |
| November 20, 2012 | K113315 | RUMBLE TUFF | HGX | Substantially Equivalent | Acute Ideas Co. , Ltd. | accessdata.fda.gov |
| November 21, 2002 | K023711 | DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE | FLL | Substantially Equivalent | Acute Ideas Co. , Ltd. | accessdata.fda.gov |
| December 18, 1995 | K952073 | PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER | FLL | Substantially Equivalent | Intelligent Product Limited Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
- All makers of Nursing Pad, Cohesive Gel
- All makers of Continuous Measurement Thermometer
- All makers of Orthosis, Lumbar
- All makers of Nursing Pad, Hydrogel
Updated March 12, 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.