Tecnol Secure-All Pelvic Traction Belt
FDA 510(k) K882640 · Tecnol New Jersey Wound Care, Inc.
510(k) numberK882640
Submission
- Device name
- Tecnol Secure-All Pelvic Traction Belt
- Applicant
- Tecnol New Jersey Wound Care, Inc.
Fort Worth, TX, US - Received
- June 27, 1988
- Decision date
- July 27, 1988
- 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 |
| K871900 | Over Drape Leg HolderKQZ · Traditional | Avec Scientific Design Corp. | 06/16/1987SE |
| K871296 | T.E.D.(Tm) Traction DeviceKQZ · Traditional | The Kendal Co. | 04/15/1987SE |
| 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 |
|---|---|---|
| K913043 | Modification Tecnol Fluidshield Surgical MasksFXX · Traditional | 08/23/1991SE |
| K911891 | Fluidshield(Tm) Cone Classic(Tm) II Surgical MaskFXX · Traditional | 07/12/1991SE |
| K911907 | Fluidshield Cone Classic II Surg Mask W/Splash VisFXX · Traditional | 07/08/1991SE |
| K896193 | Tecnol Lazer(Tm) Surgical MaskFXX · Traditional | 02/27/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | 07/25/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | 06/23/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | 05/30/1989SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | 05/23/1989SE |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | 01/17/1989SN |
| K882641 | Tecnol Catheter Leg StrapKNY · Traditional | 07/12/1988SE |
Questions and answers
When was Tecnol Secure-All Pelvic Traction Belt cleared by the FDA?
Tecnol Secure-All Pelvic Traction Belt (K882640) received a 510(k) decision of Substantially Equivalent on July 27, 1988, 30 days after the submission was received.
What is the product code of K882640?
The FDA product code is KQZ – Component, Traction, Non-Invasive, a Class I (low risk) device regulated under 21 CFR 888.5890.