Accuflex Dynamic Elbow Orthosis
FDA 510(k) K926391 · Regulatory & Marketing Services, Inc.
510(k) numberK926391
Submission
- Device name
- Accuflex Dynamic Elbow Orthosis
- Applicant
- Regulatory & Marketing Services, Inc.
Palm Florida, FL, US - Received
- December 21, 1992
- Decision date
- July 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Accuflex Dynamic Elbow Orthosis cleared by the FDA?
Accuflex Dynamic Elbow Orthosis (K926391) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 213 days after the submission was received.
What is the product code of K926391?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.