EZ-STIK ELECTRODES
FDA 510(k) clearance K050469 · decided 2005-05-13
Clearance details
- K-number
- K050469
- Device name
- EZ-STIK ELECTRODES
- Applicant
- Naimco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-23
- Decision date
- 2005-05-13
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-1 recall (Z-0815-2013) | NAImco Inc dba Richmar Inc | 2013-02-14 |
| Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x recall (Z-0816-2013) | NAImco Inc dba Richmar Inc | 2013-02-14 |
| Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 40 recall (Z-0817-2013) | NAImco Inc dba Richmar Inc | 2013-02-14 |
| Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x recall (Z-0818-2013) | NAImco Inc dba Richmar Inc | 2013-02-14 |