Data / Medical devices / United States / Navajo Manufacturing Company Inc.
Navajo Manufacturing Company Inc.: FDA-registered device maker in Denver, CO, United States, 3 510(k) clearances
Navajo Manufacturing Company Inc. is registered with the FDA (registration 1720839) in Denver, CO, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 26, 2024. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1720839
- FEI number
- 1000065475
- Address
- 5330 Fox ST., Denver, CO, United States, 80216
- Owner or operator
- Navajo Manufacturing Company Inc. (1720839)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- June 28, 2007
- Registered through
- 2026
- Brand names listed
- Denture Brush, Good to Go Toothbrush, HANDY SOLUTIONS EARLY RESULT ONE STEP PREGNANCY TEST KIT, Handy Solutions, Handy Solutions Arthritis Glove, Handy Solutions Pulse Oximeter, Handy Solutions Toothbrush, Handy Solutions Wrist Brace 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 |
|---|---|---|---|---|---|---|
| January 26, 2024 | K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | LCX | Substantially Equivalent | Nantong Egens Biotechnology Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K221798 | Finger Pulse Oximeter, Model: X1906P | DQA | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
| July 21, 2010 | K101043 | ECT DIGITAL THERMOMETER | FLL | Substantially Equivalent | Changshan Estar Electronics Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 18, 2026 | 98453 | Class I | Ongoing | Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd | If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons a | accessdata.fda.gov |
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Updated March 21, 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.