510(k) K220538
K220538 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "DolorClast Radial". The FDA issued a decision of Substantially Equivalent on July 11, 2022. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2022
- Date Received
- February 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Electric
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type