Sensor Walk
FDA 510(k) K052771 · Otto Bock Healthcare LP
510(k) numberK052771
Submission
- Device name
- Sensor Walk
- Applicant
- Otto Bock Healthcare LP
Minneapolis, MN, US - Received
- September 30, 2005
- Decision date
- May 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code IQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143458 | NeurosplintIQI · Traditional | Neurospectrum, LLC | 08/13/2015SE |
| K031576 | Spartan Orthopaedic Wrist Brace, Model SCT-1IQI · Traditional | Surgitech, Inc. | 07/31/2003SE |
| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | Mcconnell Orthopedic | 03/21/1991SE |
| 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 |
| K823160 | Rotation BootIQI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
More from Warm & Form, Orthopedic Materials
| 510(k) | Device | Decision |
|---|---|---|
| K213587 | MyCRO BandMVA · Traditional | 06/09/2022SE |
| K201426 | MyCRO BandMVA · Traditional | 03/26/2021SE |
| K113164 | Discovery Tmax Manual WheelchairIOR · Traditional | 03/11/2013SE |
| K111278 | Z10 Wheelchair Push and Brake Assist DeviceITI · Traditional | 09/16/2011SE |
| K111045 | Centro Family of Manual WheelchairsIOR · Traditional | 07/15/2011SE |
| K101524 | C2000 Powered WheelchairITI · Traditional | 09/29/2010SE |
| K082314 | Bravoracer Pediatric Manual WheelchairIOR · Traditional | 10/28/2008SE |
| K073512 | Start JuniorIOR · Traditional | 01/14/2008SE |
| K070318 | Skippi Powered Wheelchair for ChildrenITI · Traditional | 05/11/2007SE |
| K052706 | A-200 Powered WheelchairITI · Traditional | 12/27/2005SE |
Questions and answers
When was Sensor Walk cleared by the FDA?
Sensor Walk (K052771) received a 510(k) decision of Substantially Equivalent on May 3, 2006, 215 days after the submission was received.
What is the product code of K052771?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.