FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TM-300 TRACTION SYSTEM
K Number: K992545
·
Decision Sep 1, 1999
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
8
Review Days
33
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Basic Information
- Device Name
- TM-300 TRACTION SYSTEM
- K Number
- K992545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ito Co., Ltd.
- Date Received
- July 30, 1999
- Decision Date
- September 1, 1999
- 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 Ito Co., Ltd.
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|---|---|---|---|
| K203525 | D function | May 5, 2021 | Substantially Equivalent |
| K112520 | US-101L, US-103S | Oct 26, 2011 | Substantially Equivalent |
| K081943 | MODEL ES-130 | Nov 24, 2008 | Substantially Equivalent |
| K081247 | TM-400 | Aug 25, 2008 | Substantially Equivalent |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Oct 9, 2003 | Substantially Equivalent |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Jan 28, 2003 | Substantially Equivalent |
| K990787 | TRIO 300 | Oct 20, 1999 | Substantially Equivalent |