Vitalstim Experia
FDA 510(k) K070425 · Chattanooga Group
510(k) numberK070425
Submission
- Device name
- Vitalstim Experia
- Applicant
- Chattanooga Group
Hixson, TN, US - Received
- February 13, 2007
- Decision date
- June 11, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…ILY · Traditional | 09/08/2004SE |
| K040285 | Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable…IMG · Traditional | 04/12/2004SE |
| K031077 | Vectra Epr System and Intelect Epr SystemIMG · Traditional | 12/11/2003SE |
| K031116 | Vectra (Intelect) Epr UltrasoundIMI · Traditional | 12/03/2003SE |
| K023347 | Vital StimIPF · Traditional | 12/06/2002SE |
Questions and answers
When was Vitalstim Experia cleared by the FDA?
Vitalstim Experia (K070425) received a 510(k) decision of Substantially Equivalent on June 11, 2007, 118 days after the submission was received.
What is the product code of K070425?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.