Torque Frame QTF1000
FDA 510(k) K904898 · Medmetric Corp.
510(k) numberK904898
Submission
- Device name
- Torque Frame QTF1000
- Applicant
- Medmetric Corp.
San Diego, CA, US - Received
- October 30, 1990
- Decision date
- November 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKK – System, Isokinetic Testing And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1925
- Specialty
- Physical Medicine
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|---|---|---|---|
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| K952090 | Humac SystemIKK · Traditional | Computer Sports Medicine, Inc. | 12/11/1995SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | Biodex Medical Systems, Inc. | 11/16/1995SE |
| K951916 | CC Rider, Model ME180IKK · Traditional | Mettler Electronics Corp. | 10/04/1995SE |
| K950095 | Cybex 770IKK · Traditional | Cybex | 06/21/1995SE |
| K942229 | Motivator FTR 2000IKK · Traditional | Hogan & Hartson | 02/27/1995SE |
| K944732 | Dexter IsokineticIKK · Traditional | Cedaron Medical, Inc. | 02/03/1995SE |
| K924414 | The Bte Dynamic LiftIKK · Traditional | Baltimore Therapeutic Equipment Co. | 02/12/1993SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | Biodan Medical Systems, Ltd. | 07/23/1992SE |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | Biodan Medical Systems, Ltd. | 07/13/1992SE |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K943197 | KT1000/S Knee Ligament ArthrometerLYH · Traditional | 03/02/1995SE |
| K942059 | KT2000 Knee Ligament ArthrometerLYH · Traditional | 09/20/1994SE |
| K904823 | FlexercycleISD · Traditional | 01/30/1991SE |
| K854254 | Tension-IsometerLXI · Traditional | 11/15/1985SE |
| K812806 | KT-1000 DeviceLYH · Traditional | 11/10/1981SE |
| K812713 | Drawer TestFTY · Traditional | 11/05/1981SE |
| K801572 | Surg-AssistFWZ · Traditional | 08/04/1980SE |
Questions and answers
When was Torque Frame QTF1000 cleared by the FDA?
Torque Frame QTF1000 (K904898) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 29 days after the submission was received.
What is the product code of K904898?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.