Vectra Epr System and Intelect Epr System
FDA 510(k) K031077 · Chattanooga Group
510(k) numberK031077
Submission
- Device name
- Vectra Epr System and Intelect Epr System
- Applicant
- Chattanooga Group
Hixson, TN, US - Received
- April 4, 2003
- Decision date
- December 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMG – Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5860
- Specialty
- Physical Medicine
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| K244041 | Ultrasound Therapy Workstation (XMS-UET2)IMG · Traditional | Xemis Medical Technology (Shenzhen) Co., Ltd. | 10/07/2025SE |
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| K150436 | ComboRehabIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 11/13/2015SE |
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| K120217 | Sonicstimu Combo Therapeutic DeviceIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 11/21/2012SE |
| K121059 | Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimIMG · Abbreviated | Zimmer Medizinsystems GmbH | 08/07/2012SE |
| K102524 | FuturaIMG · Traditional | Dr. Oliver Wenker, M.D., M.B.A. | 11/03/2011SE |
| K111482 | Sonicator Plus 920IMG · Special | Mettler Electronics Corp. | 08/25/2011SE |
| K102190 | WinstimIMG · Special | Johari Digital Healthcare , Ltd. | 03/17/2011SE |
| K092627 | CT2011 Sonicstimu Pain Relief DeviceIMG · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 01/14/2010SE |
More from Shenzhen Dongdixin Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K090632 | Compex RehabIPF · Traditional | 06/01/2009SE |
| K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601IMJ · Traditional | 03/18/2009SE |
| K083140 | Compex Sport PlusNGX · Traditional | 02/09/2009SE |
| K070425 | Vitalstim ExperiaIPF · Traditional | 06/11/2007SE |
| K053223 | Triton/Tru-Trac/Tx/Triton DTS TractionITH · Traditional | 02/24/2006SE |
| K051938 | Triton/Tru-Trac/Tx Traction DevicesITH · Traditional | 09/21/2005SE |
| 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 |
| K031116 | Vectra (Intelect) Epr UltrasoundIMI · Traditional | 12/03/2003SE |
| K023347 | Vital StimIPF · Traditional | 12/06/2002SE |
Questions and answers
When was Vectra Epr System and Intelect Epr System cleared by the FDA?
Vectra Epr System and Intelect Epr System (K031077) received a 510(k) decision of Substantially Equivalent on December 11, 2003, 251 days after the submission was received.
What is the product code of K031077?
The FDA product code is IMG – Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5860.