Fusion
FDA 510(k) K061912 · Burke, Inc.
510(k) numberK061912
Submission
- Device name
- Fusion
- Applicant
- Burke, Inc.
Kansas City, KS, US - Received
- July 6, 2006
- Decision date
- August 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
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| K023961 | Scout BossITI · Traditional | 12/24/2002SE |
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| K965123 | Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle)INI · Traditional | 07/17/1997SE |
| K911943 | Concept Model 5200 Thermal Therapy SystemILO · Traditional | 07/19/1991SE |
| K893706 | Cold/Hot Fluid Radiation Pad NeutechILO · Traditional | 06/22/1989SE |
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Questions and answers
When was Fusion cleared by the FDA?
Fusion (K061912) received a 510(k) decision of Substantially Equivalent on August 1, 2006, 26 days after the submission was received.
What is the product code of K061912?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.