Data / Medical devices / United States / Nuvomed Inc
Nuvomed Inc: FDA-registered device maker in Broadview, IL, United States, 6 510(k) clearances
Nuvomed Inc is registered with the FDA (registration 3014449259) in Broadview, IL, United States. It lists 15 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014449259
- Address
- 2101 W 21st St, Broadview, IL, United States, 60155
- Owner or operator
- Nuvomed Inc (10059387)
- Roles
- Repackager or relabeler
- First device listed
- April 14, 2020
- Registered through
- 2026
- Brand names listed
- Air Massager, Arm Blood Pressure Monitor, Digital Contactless Thermometer, Great Health, Hearing Aid, Hot & Cold Therapy Pad, Hot & Cold Therapy Sleeve, Kids Digital Thermometer, Digital Thermometer and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 25, 2024 | K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | DQA | Substantially Equivalent | Shenzhen Yimi Life Technology Co., Ltd. | accessdata.fda.gov |
| December 1, 2022 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K203347 | Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask | BZD | Substantially Equivalent | Suzhou Yuyue Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 17, 2020 | K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | FLL | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| June 22, 2016 | K152863 | Portable ECG Monitor | DPS | Substantially Equivalent | Contec Medical Systems Co.,Ltd | accessdata.fda.gov |
Compare with other makers
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Updated May 2, 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.