Cynosure Triactive Therapeutic Massage System
FDA 510(k) K030876 · Cynosure, Inc.
510(k) numberK030876
Submission
- Device name
- Cynosure Triactive Therapeutic Massage System
- Applicant
- Cynosure, Inc.
Chelmsford, MA, US - Received
- March 20, 2003
- Decision date
- January 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Cynosure Triactive Therapeutic Massage System cleared by the FDA?
Cynosure Triactive Therapeutic Massage System (K030876) received a 510(k) decision of Substantially Equivalent on January 22, 2004, 308 days after the submission was received.
What is the product code of K030876?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.