FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
K Number: K083433
·
Decision Mar 18, 2009
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
11
Review Days
118
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Basic Information
- Device Name
- INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
- K Number
- K083433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chattanooga Group
- Date Received
- November 20, 2008
- Decision Date
- March 18, 2009
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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| 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 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Dec 3, 2003 | Substantially Equivalent |
| K023347 | VITAL STIM | Dec 6, 2002 | Substantially Equivalent |