Mini Vibrator
FDA 510(k) K920487 · Alimed, Inc.
510(k) numberK920487
Submission
- Device name
- Mini Vibrator
- Applicant
- Alimed, Inc.
Dedham, MA, US - Received
- January 30, 1992
- Decision date
- February 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IRO – Vibrator, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5975
- Specialty
- Physical Medicine
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Questions and answers
When was Mini Vibrator cleared by the FDA?
Mini Vibrator (K920487) received a 510(k) decision of Substantially Equivalent on February 18, 1992, 19 days after the submission was received.
What is the product code of K920487?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.