Cordless Electric Massager EV315
FDA 510(k) K912634 · Matsushita Electric Co.
510(k) numberK912634
Submission
- Device name
- Cordless Electric Massager EV315
- Applicant
- Matsushita Electric Co.
Washington, DC, US - Received
- June 14, 1991
- Decision date
- September 12, 1991
- 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 Cordless Electric Massager EV315 cleared by the FDA?
Cordless Electric Massager EV315 (K912634) received a 510(k) decision of Substantially Equivalent on September 12, 1991, 90 days after the submission was received.
What is the product code of K912634?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.