Data / Medical devices / United States / WR Medical Electronics Co.
WR Medical Electronics Co.: FDA-registered device maker in Maplewood, MN, United States, 6 510(k) clearances
WR Medical Electronics Co. is registered with the FDA (registration 2118418) in Maplewood, MN, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 19, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2118418
- Address
- 1700 Gervais Ave, Maplewood, MN, United States, 55109
- Owner or operator
- WR MEDICAL ELECTRONICS CO. (2118418)
- Roles
- Manufacturer
- First device listed
- November 9, 2007
- Registered through
- 2026
- Brand names listed
- CASEIV, HRV Acquire, Iontophor, Meridian, QSweat, Therabath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bath, Paraffin | IMC | 2 | Manufacturer | accessdata.fda.gov |
| Device, Iontophoresis, Other Uses | EGJ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Iontophoresis, Specific Uses | KTB | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vibration Threshold Measurement | LLN | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | 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 |
|---|---|---|---|---|---|---|
| October 19, 2010 | K092809 | HRV ACQUIRE | DRT | Substantially Equivalent | Wr Medical Electronics Co. | accessdata.fda.gov |
| August 9, 2000 | K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) | EGJ | Substantially Equivalent | Wr Medical Electronics Co. | accessdata.fda.gov |
| November 18, 1999 | K992874 | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | KTB | Substantially Equivalent | Wr Medical Electronics Co. | accessdata.fda.gov |
| January 17, 1992 | K910624 | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | LLN | Substantially Equivalent | Wr Medical Electronics Co. | accessdata.fda.gov |
| August 11, 1987 | K871869 | MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. | EGJ | Unknown | Life-Tech Intl., Inc. | accessdata.fda.gov |
| March 4, 1987 | K863166 | MODEL 6110 IONTOPHORETIC APPLICATOR | EGJ | Substantially Equivalent | Life-Tech Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Iontophoresis, Other Uses
- All makers of Device, Iontophoresis, Specific Uses
- All makers of Device, Vibration Threshold Measurement
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Bath, Paraffin
Updated October 19, 2010. 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.