Secutex Wrist Brace
FDA 510(k) K791249 · Conphar, Inc.
510(k) numberK791249
Submission
- Device name
- Secutex Wrist Brace
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- July 6, 1979
- Decision date
- July 24, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQI – Orthosis, Limb Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
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| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
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| K874502 | Gait-Aid Orthopedic InsoleIQI · Traditional | Gait-Aid, Inc. | 11/30/1987SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831615 | Drop Foot BraceIQI · Traditional | Edward Dilauro, Jr. | 06/15/1983SE |
| K823812 | Various Supports and SplintsIQI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
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| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Secutex Wrist Brace cleared by the FDA?
Secutex Wrist Brace (K791249) received a 510(k) decision of Substantially Equivalent on July 24, 1979, 18 days after the submission was received.
What is the product code of K791249?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.