510(k) K210284
K210284 is an FDA 510(k) premarket notification submitted by Manamed, Inc. for the device "ManaSport". The FDA issued a decision of Substantially Equivalent on April 26, 2022. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Manamed, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2022
- Date Received
- February 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type