510(k) K211513
K211513 is an FDA 510(k) premarket notification submitted by ZetrOZ Systems, LLC for the device "sam X1 Long Duration Ultrasound Device". The FDA issued a decision of Substantially Equivalent on August 18, 2021. 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. ZetrOZ Systems, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2021
- Date Received
- May 14, 2021
- Clearance Type
- Special
- 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.