510(k) K933974
K933974 is an FDA 510(k) premarket notification submitted by Windmere Corp. for the device "WINDMERE MASSAGE MATE". The FDA issued a decision of Substantially Equivalent on February 2, 1994. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Windmere Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1994
- Date Received
- August 13, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type