Head Halter
FDA 510(k) K830245 · Warm & Form, Orthopedic Materials
510(k) numberK830245
Submission
- Device name
- Head Halter
- Applicant
- Warm & Form, Orthopedic Materials
Mchenry, IL, US - Received
- January 25, 1983
- Decision date
- March 9, 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 |
| K831135 | Saunders #7080 Cervical Traction SysILZ · Traditional | Chattanooga Group, Inc. | 06/24/1983SE |
| 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 |
|---|---|---|
| K830244 | Traction AccessoriesHST · Traditional | 03/09/1983SE |
| K830243 | Abduction PillowIOZ · Traditional | 03/08/1983SE |
| K830246 | Cast Shoe, Cast BootJQB · Traditional | 02/18/1983SE |
| K823667 | Cervical CollarIQK · Traditional | 12/30/1982SE |
| K823666 | Universal Wrist Splint & Forearm SplintILH · Traditional | 12/30/1982SE |
| K823665 | Rotation BootKNP · Traditional | 12/30/1982SE |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | 12/30/1982SE |
| K823663 | Abdominal BinderKTD · Traditional | 12/30/1982SE |
| K823662 | Rib Belt (Universal)IPX · Traditional | 12/30/1982SE |
| K823661 | Clavicle SupportIQJ · Traditional | 12/30/1982SE |
Questions and answers
When was Head Halter cleared by the FDA?
Head Halter (K830245) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 43 days after the submission was received.
What is the product code of K830245?
The FDA product code is ILZ – Accessories, Traction, a Class I (low risk) device regulated under 21 CFR 890.5925.