Windmere Prelude III
FDA 510(k) K924237 · Windmere Corp.
510(k) numberK924237
Submission
- Device name
- Windmere Prelude III
- Applicant
- Windmere Corp.
Miami Lakes, FL, US - Received
- August 24, 1992
- Decision date
- October 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISA – Massager, Therapeutic, Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
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Questions and answers
When was Windmere Prelude III cleared by the FDA?
Windmere Prelude III (K924237) received a 510(k) decision of Substantially Equivalent on October 18, 1993, 420 days after the submission was received.
What is the product code of K924237?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.