Ankle/Foot External
FDA 510(k) K820505 · Mauch Laboratories, Inc.
510(k) numberK820505
Submission
- Device name
- Ankle/Foot External
- Applicant
- Mauch Laboratories, Inc.
Mchenry, IL, US - Received
- February 25, 1982
- Decision date
- March 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISH – Component, External, Limb, Ankle/Foot
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Specialty
- Physical Medicine
Other 510(k)s with product code ISH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051256 | Silverseal Orthotic Component with X-StaticISH · Traditional | Noble Fiber Technologies, Inc. | 07/21/2005SE |
| K823396 | Free Flex Heel Height AdjustorISH · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K791331 | The Tucker-Sach Foot and Tucker-Syme FTISH · Traditional | Kiswood Manufacturing, Inc. | 08/03/1979SE |
Questions and answers
When was Ankle/Foot External cleared by the FDA?
Ankle/Foot External (K820505) received a 510(k) decision of Substantially Equivalent on March 8, 1982, 11 days after the submission was received.
What is the product code of K820505?
The FDA product code is ISH – Component, External, Limb, Ankle/Foot, a Class I (low risk) device regulated under 21 CFR 890.3420.