510(k) K173692
K173692 is an FDA 510(k) premarket notification submitted by Storz Medical AG for the device "D-Actor 200 Vibration Massage System". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Storz Medical AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2018
- Date Received
- December 1, 2017
- 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