510(k) K924237
K924237 is an FDA 510(k) premarket notification submitted by Windmere Corp. for the device "WINDMERE PRELUDE III". The FDA issued a decision of Substantially Equivalent on October 18, 1993. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Windmere Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1993
- Date Received
- August 24, 1992
- 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