Traction Accessories
FDA 510(k) K844490 · Jerome Medical
510(k) numberK844490
Submission
- Device name
- Traction Accessories
- Applicant
- Jerome Medical
Mt Laurel, NJ, US - Received
- November 20, 1984
- Decision date
- February 21, 1985
- 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 |
| K831135 | Saunders #7080 Cervical Traction SysILZ · Traditional | Chattanooga Group, Inc. | 06/24/1983SE |
| 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 |
More from Dr. K.G. Rude
| 510(k) | Device | Decision |
|---|---|---|
| K051918 | Resolve Open Back Halo RingsHAX · Special | 08/17/2005SE |
| K930021 | J TongsHAX · Traditional | 12/06/1995SE |
| K930153 | System III Halo RingJEC · Traditional | 08/06/1993SE |
| K882877 | JMS Cervical Traction Device/Halo DeviceJEC · Traditional | 09/30/1988SE |
| K870053 | Torquedriver WrenchHXC · Traditional | 03/11/1987SE |
| K864969 | JMS Halo Application TrayKDD · Traditional | 02/18/1987SESD |
| K822780 | Cervical BraceJEC · Traditional | 10/06/1982SE |
| K821582 | Warm'N Form Sports SupportsIQI · Traditional | 06/10/1982SE |
Questions and answers
When was Traction Accessories cleared by the FDA?
Traction Accessories (K844490) received a 510(k) decision of Substantially Equivalent on February 21, 1985, 93 days after the submission was received.
What is the product code of K844490?
The FDA product code is ILZ – Accessories, Traction, a Class I (low risk) device regulated under 21 CFR 890.5925.