LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
FDA 510(k) clearance K010431 · decided 2001-09-06
Clearance details
- K-number
- K010431
- Device name
- LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
- Applicant
- Lead-Lok, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-13
- Decision date
- 2001-09-06
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sandpoint, ID, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lead-Lok
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.