WELLNESS/JOLIVETE
FDA 510(k) clearance K040905 · decided 2005-02-23
Clearance details
- K-number
- K040905
- Device name
- WELLNESS/JOLIVETE
- Applicant
- Tohkai Precision Ind. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-07
- Decision date
- 2005-02-23
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Saint Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.