FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VECTRA (INTELECT) EPR ULTRASOUND
K Number: K031116
·
Decision Dec 3, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
11
Review Days
239
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Basic Information
- Device Name
- VECTRA (INTELECT) EPR ULTRASOUND
- K Number
- K031116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chattanooga Group
- Date Received
- April 8, 2003
- Decision Date
- December 3, 2003
- Product Code
- IMI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Chattanooga Group
| K Number | Device Name | ||
|---|---|---|---|
| K090632 | COMPEX REHAB | Jun 1, 2009 | Substantially Equivalent |
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 | Mar 18, 2009 | Substantially Equivalent |
| K083140 | COMPEX SPORT PLUS | Feb 9, 2009 | Substantially Equivalent |
| K070425 | VITALSTIM EXPERIA | Jun 11, 2007 | Substantially Equivalent |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Feb 24, 2006 | Substantially Equivalent |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | Sep 21, 2005 | Substantially Equivalent |
| K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | Sep 8, 2004 | Substantially Equivalent |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | Apr 12, 2004 | Substantially Equivalent |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Dec 11, 2003 | Substantially Equivalent |
| K023347 | VITAL STIM | Dec 6, 2002 | Substantially Equivalent |