Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
FDA 510(k) clearance K222528 · decided 2022-12-29
Clearance details
- K-number
- K222528
- Device name
- Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
- Applicant
- Well-Life Healthcare Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-08-22
- Decision date
- 2022-12-29
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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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.