FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAL STIM
K Number: K023347
·
Decision Dec 6, 2002
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
11
Review Days
60
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Basic Information
- Device Name
- VITAL STIM
- K Number
- K023347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chattanooga Group
- Date Received
- October 7, 2002
- Decision Date
- December 6, 2002
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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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 |
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| K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | Sep 8, 2004 | Substantially Equivalent |
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| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Dec 11, 2003 | Substantially Equivalent |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Dec 3, 2003 | Substantially Equivalent |