FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORQUE FRAME QTF1000
K Number: K904898
·
Decision Nov 28, 1990
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
60
Applicant Total
8
Review Days
29
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Basic Information
- Device Name
- TORQUE FRAME QTF1000
- K Number
- K904898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medmetric Corp.
- Date Received
- October 30, 1990
- Decision Date
- November 28, 1990
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
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Other Clearances by Medmetric Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943197 | KT1000/S KNEE LIGAMENT ARTHROMETER | Mar 2, 1995 | Substantially Equivalent |
| K942059 | KT2000 KNEE LIGAMENT ARTHROMETER | Sep 20, 1994 | Substantially Equivalent |
| K904823 | FLEXERCYCLE | Jan 30, 1991 | Substantially Equivalent |
| K854254 | TENSION-ISOMETER | Nov 15, 1985 | Substantially Equivalent |
| K812806 | KT-1000 DEVICE | Nov 10, 1981 | Substantially Equivalent |
| K812713 | DRAWER TEST | Nov 5, 1981 | Substantially Equivalent |
| K801572 | SURG-ASSIST | Aug 4, 1980 | Substantially Equivalent |