TPG 1000
FDA 510(k) K831002 · Physical Diagnostics, Inc.
510(k) numberK831002
Submission
- Device name
- TPG 1000
- Applicant
- Physical Diagnostics, Inc.
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- June 24, 1983
- 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 |
| K871296 | T.E.D.(Tm) Traction DeviceKQZ · Traditional | The Kendal Co. | 04/15/1987SE |
| K854270 | Murphy Adjustable SplintKQZ · Traditional | Comfortex, Inc. | 12/09/1985SE |
| 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 |
Questions and answers
When was TPG 1000 cleared by the FDA?
TPG 1000 (K831002) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 87 days after the submission was received.
What is the product code of K831002?
The FDA product code is KQZ – Component, Traction, Non-Invasive, a Class I (low risk) device regulated under 21 CFR 888.5890.