4000 PT Exercise System
FDA 510(k) K912057 · Tri-Tech, Inc.
510(k) numberK912057
Submission
- Device name
- 4000 PT Exercise System
- Applicant
- Tri-Tech, Inc.
Fort Woth, TX, US - Received
- May 9, 1991
- Decision date
- October 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
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| K962855 | ULE-2, MULE-2, Hand Accessory KitISD · Traditional | Penny and Giles Biometrics , Ltd. | 12/11/1996SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971111 | Tri-Tech Inc., Evacuated Blood Collection Tube, Gray StopperJKA · Traditional | 06/16/1997SE |
| K952246 | Tri-Techin. Custom Blood And/Or Urine Transport KitJXA · Traditional | 06/20/1995SE |
| K922343 | Tri-Tech Inc. Custom Sexual Assault KitJKA · Traditional | 02/17/1994SESK |
| K922342 | Tri-Tech Inc. Custom Blood AlcoholJKA · Traditional | 08/27/1993SEKD |
| K912140 | Stairmaster Model 6000 ErgometerISD · Traditional | 12/17/1991SE |
| K912058 | Gauntlet Stair ClimberISD · Traditional | 10/24/1991SE |
| K912056 | Gravitron Upper Body System ExerciserISD · Traditional | 10/24/1991SE |
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | 09/17/1990SE |
| K843839 | Stat/Pb ReagentDOF · Traditional | 01/03/1985SE |
| K813075 | Tritec Doc TMBZD · Traditional | 12/09/1981SE |
Questions and answers
When was 4000 PT Exercise System cleared by the FDA?
4000 PT Exercise System (K912057) received a 510(k) decision of Substantially Equivalent on October 24, 1991, 168 days after the submission was received.
What is the product code of K912057?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.