KQZ
11 FDA 510(k) clearances · Product code
27 daysmedian time to decision
53 days90th percentile
11clearances measured
FDA profile
- Official device name
- Component, Traction, Non-Invasive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5890
- Medical specialty
- Orthopedic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 3 · 1998: 1 · 2001: 2 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TECNOL BUCKS TRACTION W/HEEL PROTECTOR (K884132) | Technol, Inc. | 1988-10-11 |
| TECNOL SECURE-ALL PELVIC TRACTION BELT (K882640) | Tecnol New Jersey Wound Care, Inc. | 1988-07-27 |
| OVER DRAPE LEG HOLDER (K871900) | Avec Scientific Design Corp. | 1987-06-16 |
| T.E.D.(TM) TRACTION DEVICE (K871296) | The Kendal Co. | 1987-04-15 |
| MURPHY ADJUSTABLE SPLINT (K854270) | Comfortex, Inc. | 1985-12-09 |
| TPG 1000 (K831002) | Physical Diagnostics, Inc. | 1983-06-24 |
| UNIVERSAL BUCKS TRACTION (K823660) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| UNIVERSAL BUCKS TRACTION (K823163) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| HOFFMAN UNIVERSAL FOOT SUPPORT (K821252) | Howmedica Corp. | 1982-06-22 |
| BACKTRAC 90-90 TRACTION (K802869) | Backtrac | 1980-12-11 |
| SPLINT, HOAKE INFLATABLE AIR (K781754) | Depuy, Inc. | 1978-11-08 |
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Every clearance here is in the API, with alerts when new ones post.