Autorange
FDA 510(k) K781997 · Tri W-G, Inc.
510(k) numberK781997
Submission
- Device name
- Autorange
- Applicant
- Tri W-G, Inc.
Mchenry, IL, US - Received
- November 30, 1978
- Decision date
- January 8, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal…ISD · Abbreviated | Lode B.V. | 12/21/2020SE |
| K183296 | REAL Immersive SystemISD · Traditional | Penumbra, Inc. | 03/18/2019SE |
| K143512 | ActiSpec Activity MonitorISD · Traditional | Sleep Modus, Inc. | 08/26/2015SE |
| K112121 | Ergoselect/GeISD · Traditional | Ergoline GmbH | 10/31/2012SE |
| K080545 | ActitrainerISD · Traditional | Actigraph, LLC | 07/24/2008SE |
| K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PISD · Traditional | Ergoline GmbH | 04/27/2006SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| 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 |
|---|---|---|
| K960196 | Tri W-G, Inc Table, Tilt/Exam/Treatment Model 777INQ · Traditional | 02/07/1996SE |
| K945163 | EchocardiographyLGX · Traditional | 02/17/1995SE |
| K941720 | Model 747 and 747-30 Exam/Treatment TableINQ · Traditional | 05/06/1994SE |
| K936303 | Treatment Table ModificationINQ · Traditional | 03/18/1994SE |
| K933119 | Hi-Lo Treatment TablesINQ · Traditional | 10/12/1993SE |
| K932746 | Model T4501,T4502,T4503,T4504,T4504 Tilt TableINQ · Traditional | 07/21/1993SE |
| K930802 | Models 642 & 643 Tilt Exam/Treatment TableINQ · Traditional | 03/22/1993SE |
| K925594 | MDL 29001 Medi Elec-Mech Tilt Exam/Treatment TableINQ · Traditional | 02/12/1993SE |
| K923325 | Model 600 Medical Treatment TableINQ · Traditional | 07/21/1992SE |
| K922980 | 745-M (Magnum)JFB · Traditional | 07/13/1992SE |
Questions and answers
When was Autorange cleared by the FDA?
Autorange (K781997) received a 510(k) decision of Substantially Equivalent on January 8, 1979, 39 days after the submission was received.
What is the product code of K781997?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.