510(k) K081075
K081075 is an FDA 510(k) premarket notification submitted by Nano Vibronix , Ltd. for the device "PAINSHIELD MD". The FDA issued a decision of Substantially Equivalent on August 22, 2008. The device falls under product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2008
- Date Received
- April 16, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.