FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTELECT MODEL 200
K Number: K813593
·
Decision Feb 22, 1982
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
70
Review Days
87
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Basic Information
- Device Name
- INTELECT MODEL 200
- K Number
- K813593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Chattanooga Group, Inc.
- Date Received
- November 27, 1981
- Decision Date
- February 22, 1982
- 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Jul 6, 2001 | Substantially Equivalent |
| K982317 | VECTRA COMBO | Feb 1, 1999 | Substantially Equivalent |
| K982324 | VECTRA PRO MODELS 2 AND 4 | Feb 1, 1999 | Substantially Equivalent |
| K982321 | VECTRA STIM MODELS 200 AND 400 | Feb 1, 1999 | Substantially Equivalent |
| K982829 | FORTE, MODEL CPS ULTRASOUND | Nov 6, 1998 | Substantially Equivalent |
| K982828 | FORTE, MODELS CPS 400 STIM, CPS 200 STIM | Nov 6, 1998 | Substantially Equivalent |
| K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO | Nov 6, 1998 | Substantially Equivalent |
| K980718 | PARA-CARE | Mar 27, 1998 | Substantially Equivalent |
| K974497 | INTELECT | Jan 23, 1998 | Substantially Equivalent |
| K973024 | INTELECT LEGEND ULTRASOUND | Nov 10, 1997 | Substantially Equivalent |