REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
FDA 510(k) clearance K901575 · decided 1990-05-02
Clearance details
- K-number
- K901575
- Device name
- REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
- Applicant
- Pioneering Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-03
- Decision date
- 1990-05-02
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Wabasha, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S. recall (Z-0498-2013) | Covidien LLC dba Uni-Patch | 2012-12-10 |