T.E.D.(Tm) Traction Device
FDA 510(k) K871296 · The Kendal Co.
510(k) numberK871296
Submission
- Device name
- T.E.D.(Tm) Traction Device
- Applicant
- The Kendal Co.
Boston, MA, US - Received
- March 31, 1987
- Decision date
- April 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQZ – Component, Traction, Non-Invasive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5890
- Specialty
- Orthopedic
Other 510(k)s with product code KQZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884132 | Tecnol Bucks Traction W/Heel ProtectorKQZ · Traditional | Technol, Inc. | 10/11/1988SE |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/27/1988SE |
| K871900 | Over Drape Leg HolderKQZ · Traditional | Avec Scientific Design Corp. | 06/16/1987SE |
| K854270 | Murphy Adjustable SplintKQZ · Traditional | Comfortex, Inc. | 12/09/1985SE |
| K831002 | TPG 1000KQZ · Traditional | Physical Diagnostics, Inc. | 06/24/1983SE |
| K823660 | Universal Bucks TractionKQZ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823163 | Universal Bucks TractionKQZ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K821252 | Hoffman Universal Foot SupportKQZ · Traditional | Howmedica Corp. | 06/22/1982SE |
| K802869 | Backtrac 90-90 TractionKQZ · Traditional | Backtrac | 12/11/1980SE |
| K781754 | Splint, Hoake Inflatable AirKQZ · Traditional | Depuy, Inc. | 11/08/1978SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000087 | Marhukar Triple Lumen Catheter, Model 12 FRFOZ · Traditional | 03/17/2000SE |
| K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…EZL · Abbreviated | 09/28/1999SE |
| K991758 | Monoject Insulin SyringeFMF · Abbreviated | 06/14/1999SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | 04/23/1997SE |
| K951488 | Kendall Curity Catheter Plug with Protective CapKNY · Traditional | 04/25/1995SE |
| K942664 | Kendall Model 6325 SCD Sequel Compression SystemJOW · Traditional | 01/17/1995SE |
| K942774 | Polyskin(R) M.R. Moist Responsive Transparent DressingMGP · Traditional | 07/20/1994SN |
| K892434 | Kendall Curity Oxygen MaskBYG · Traditional | 08/15/1989SE |
| K892440 | Kendall Curity Extension TubesFPA · Traditional | 07/24/1989SE |
| K892438 | Kendall Curity Intravascular Cut Down TubesFPA · Traditional | 07/24/1989SE |
Questions and answers
When was T.E.D.(Tm) Traction Device cleared by the FDA?
T.E.D.(Tm) Traction Device (K871296) received a 510(k) decision of Substantially Equivalent on April 15, 1987, 15 days after the submission was received.
What is the product code of K871296?
The FDA product code is KQZ – Component, Traction, Non-Invasive, a Class I (low risk) device regulated under 21 CFR 888.5890.