PAINSHIELD MD
FDA 510(k) clearance K081075 · decided 2008-08-22
Clearance details
- K-number
- K081075
- Device name
- PAINSHIELD MD
- Applicant
- Nano Vibronix , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-16
- Decision date
- 2008-08-22
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- PFW
- Device class
- 2
- Regulation number
- 890.5300
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Efrat, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.