FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRITON/TRU-TRAC/TX TRACTION DEVICES
K Number: K051938
·
Decision Sep 21, 2005
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
11
Review Days
65
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Basic Information
- Device Name
- TRITON/TRU-TRAC/TX TRACTION DEVICES
- K Number
- K051938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chattanooga Group
- Date Received
- July 18, 2005
- Decision Date
- September 21, 2005
- Product Code
- ITH
- 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 |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Chattanooga Group
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|---|---|---|---|
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| 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 |
| 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 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Dec 3, 2003 | Substantially Equivalent |
| K023347 | VITAL STIM | Dec 6, 2002 | Substantially Equivalent |