Otto Bock Orthopedic Industry, Inc.: FDA clearances and approvals
Otto Bock Orthopedic Industry, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2000), across 3 product codes in 1 review panel. Median 510(k) review time: 42 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 3 | 3 |
| ITI | Wheelchair, Powered | 2 | 2 |
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 1 | 1 |
Review panels
Most recent Otto Bock Orthopedic Industry, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000739 | EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR | ITI | 2000-10-24 | 231 |
| K000678 | RAEBBITT/EVOLUTION POWERED WHEELCHAIR | ITI | 2000-09-18 | 202 |
| K000497 | VOYAGER/VIPER WHEELCHAIR | IOR | 2000-03-08 | 22 |
| K000602 | PROTEGE WHEELCHAIR | IOR | 2000-03-03 | 9 |
| K991590 | C-LEG (3C100) | ISW | 1999-07-08 | 62 |
| K951847 | AVANTGARDE | IOR | 1995-05-12 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Otto Bock Orthopedic Industry, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Otto Bock Orthopedic Industry, Inc. have?
Otto Bock Orthopedic Industry, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2000), across 3 product codes in 1 review panel.
How long does FDA take to clear Otto Bock Orthopedic Industry, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Otto Bock Orthopedic Industry, Inc.'s cleared 510(k)s is 42 days.
What devices does Otto Bock Orthopedic Industry, Inc. make?
Its most frequent FDA product codes are IOR (Wheelchair, Mechanical, 3); ITI (Wheelchair, Powered, 2); ISW (Assembly, Knee/Shank/Ankle/Foot, External, 1).
Has Otto Bock Orthopedic Industry, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Otto Bock Orthopedic Industry, Inc. Related entities may recall under other names.
Next steps
- See all 6 Otto Bock Orthopedic Industry, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Otto Bock Orthopedic Industry, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.