Traction Accessories
FDA 510(k) K830244 · Warm & Form, Orthopedic Materials
510(k) numberK830244
Submission
- Device name
- Traction Accessories
- 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
- HST – Apparatus, Traction, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5850
- Specialty
- Orthopedic
Other 510(k)s with product code HST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162702 | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation…HST · Traditional | Stl International, Inc. | 12/30/2016SE |
| K110858 | Lo-Bak TraxHST · Traditional | Roland F Berthiaume, DC | 08/02/2011SE |
| K984190 | Back-On-Trac, Model 101BOTHST · Traditional | Back-On-Track, Inc. | 03/15/1999SE |
| K872121 | K and D Home TractHST · Traditional | Joseph A. Kott, M.D. | 08/12/1987SE |
| K870212 | Arthroscopic Shoulder HolderHST · Traditional | Dyonics, Inc. | 02/20/1987SE |
| K870125 | Extremity ElevatorHST · Traditional | Orthopedic Systems, Inc. | 02/04/1987SE |
| K870102 | Tupper TrolleyHST · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K864765 | Model 668, Traction Splint, AdultHST · Traditional | Ferno-Washington, Inc. | 12/17/1986SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | Lossing Orthopedic, Inc. | 08/07/1986SE |
| K860037 | Suspender Orthopedic Suspension DeviceHST · Traditional | Comfortex, Inc. | 01/21/1986SE |
More from Comfortex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830245 | Head HalterILZ · 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 Traction Accessories cleared by the FDA?
Traction Accessories (K830244) 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 K830244?
The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.