Brace-Up All Purpose Wrist Band

FDA 510(k) K823113 · Arco Matic, Inc.

Substantially Equivalent

510(k) numberK823113

Submission

Device name
Brace-Up All Purpose Wrist Band
Applicant
Arco Matic, Inc.
Mchenry, IL, US
Received
October 21, 1982
Decision date
November 16, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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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More from Warm & Form, Orthopedic Materials

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Questions and answers

When was Brace-Up All Purpose Wrist Band cleared by the FDA?

Brace-Up All Purpose Wrist Band (K823113) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 26 days after the submission was received.

What is the product code of K823113?

The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.