LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
FDA 510(k) clearance K040512 · decided 2004-05-27
Clearance details
- K-number
- K040512
- Device name
- LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
- Applicant
- Well-Life Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-27
- Decision date
- 2004-05-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Madison, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.