Data / Medical devices / China / Hunan Accurate Bio-Medical Technology Co., Ltd.
Hunan Accurate Bio-Medical Technology Co., Ltd.: FDA-registered device maker in Changsha Hunan, China, 5 510(k) clearances
Hunan Accurate Bio-Medical Technology Co., Ltd. is registered with the FDA (registration 3011353016) in Changsha Hunan, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011353016
- Address
- Accurate Industrial Park, No.108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, Changsha Hunan, China, 410208
- Owner or operator
- Hunan Accurate Bio-Medical Technology Co., Ltd. (10048204)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 16, 2014
- Registered through
- 2026
- Brand names listed
- Concord Fingertip Pulse Oximeter (model: 75079); Concord Handheld Pulse Oximeter (model: 75023), Concord Wrist Oximeter (model: 75044,75044B), FS10A,FS20A,FS10C,FS20C,FS10D,FS20D,FS10E,FS20E,HS10A,HS20A,, Handheld Pulse Oximeter (model: HS20A), Handheld Pulse Oximeter-Rechargeable (model: 75023R), NASAL IRRIGATOR (model: NS1A3, NS2A3, NS3A3, NS1C3, NS2C3, NS3C3, NS1D3), Nasal Irrigator (model: NH2A1, NH2A3, NH3A5, NH2B3, NH2C3, NH2D3, NH2D4, NH2E3, NH2F3, NH2G3), Pelvic Floor Exerciser (model: PF01, PF02, PF03) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vibrator For Therapeutic Use, Genital | KXQ | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 27, 2026 | K252748 | Pelvic Floor Exerciser (PF01) | HIR | Substantially Equivalent | Hunan Accurate Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 2, 2025 | K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | DQA | Substantially Equivalent | Hunan Accurate Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 3, 2024 | K240808 | Pulse Oximeter (WS20A) | DQA | Substantially Equivalent | Hunan Accurate Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 27, 2018 | K171241 | Pulse Oximeter | DQA | Substantially Equivalent | Hunan Accurate Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 4, 2014 | K141105 | PULSE OXIMETER | DQA | Substantially Equivalent | Hunan Accurate Bio-Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Wellness
- All makers of Vibrator For Therapeutic Use, Genital
- All makers of Irrigator, Powered Nasal
- All makers of Oximeter
- All makers of Perineometer
- All makers of Unit, Oral Irrigation
Updated April 27, 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.