Saunders #7080 Cervical Traction Sys
FDA 510(k) K831135 · Chattanooga Group, Inc.
510(k) numberK831135
Submission
- Device name
- Saunders #7080 Cervical Traction Sys
- Applicant
- Chattanooga Group, Inc.
Mchenry, IL, US - Received
- April 7, 1983
- Decision date
- June 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILZ – Accessories, Traction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5925
- Specialty
- Physical Medicine
Other 510(k)s with product code ILZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921711 | Flexion Distration SupportILZ · Traditional | Altoona Medical Supply | 07/13/1992SE |
| K895382 | Vibra-Trac Traction TableILZ · Traditional | Vibra-Trac Industries | 10/16/1989SE |
| K884340 | AMX-110, Amx-Ii and Amx-IiiILZ · Traditional | Dyna-Med | 01/24/1989SE |
| K852398 | Vector Bar Suspension/Traction UnitILZ · Traditional | Powlan Manufacturing Co. | 08/12/1985SE |
| K844490 | Traction AccessoriesILZ · Traditional | Jerome Medical | 02/21/1985SE |
| K830245 | Head HalterILZ · Traditional | Warm & Form, Orthopedic Materials | 03/09/1983SE |
| K823659 | Pelvic Traction BeltILZ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823166 | Pelvic Traction BeltILZ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K820663 | Boger Auto-Traction DeviceILZ · Traditional | D.C. Medical Device, Inc. | 05/03/1982SE |
| K791808 | Cervi-TracILZ · Traditional | Dr. K.G. Rude | 10/01/1979SE |
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| K083140 | Compex Sport PlusNGX · Traditional | 02/09/2009SE |
| K070425 | Vitalstim ExperiaIPF · Traditional | 06/11/2007SE |
| K053223 | Triton/Tru-Trac/Tx/Triton DTS TractionITH · Traditional | 02/24/2006SE |
| K051938 | Triton/Tru-Trac/Tx Traction DevicesITH · Traditional | 09/21/2005SE |
| K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…ILY · Traditional | 09/08/2004SE |
| K040285 | Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable…IMG · Traditional | 04/12/2004SE |
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Questions and answers
When was Saunders #7080 Cervical Traction Sys cleared by the FDA?
Saunders #7080 Cervical Traction Sys (K831135) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 78 days after the submission was received.
What is the product code of K831135?
The FDA product code is ILZ – Accessories, Traction, a Class I (low risk) device regulated under 21 CFR 890.5925.