Heelbo, Inc.: FDA clearances and approvals
Heelbo, Inc. has 14 FDA 510(k) clearances (first 1996, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time: 84 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 14 | 14 |
Review panels
- General Hospital (14)
Most recent Heelbo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980640 | HEELBO WAIST AND CHEST VEST | FMQ | 1998-05-01 | 71 |
| K963372 | HEELBO ER WRIST RESTRAINT | FMQ | 1996-11-07 | 72 |
| K963060 | HEELBO SECURITY BELT | FMQ | 1996-11-04 | 89 |
| K963099 | HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET | FMQ | 1996-11-01 | 84 |
| K963041 | HEELBO LIFE JACKET WITH CROTCH SUPPORT | FMQ | 1996-10-31 | 87 |
| K962839 | HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP | FMQ | 1996-10-18 | 88 |
| K962834 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP | FMQ | 1996-10-18 | 88 |
| K962832 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP | FMQ | 1996-10-18 | 88 |
| K962831 | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE | FMQ | 1996-10-18 | 88 |
| K963294 | HEELBO WRAP AROUND VEST | FMQ | 1996-10-11 | 51 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Heelbo, 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 Heelbo, Inc. have?
Heelbo, Inc. has 14 FDA 510(k) clearances (first 1996, latest 1998), across 1 product code in 1 review panel.
How long does FDA take to clear Heelbo, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Heelbo, Inc.'s cleared 510(k)s is 84 days.
What devices does Heelbo, Inc. make?
Its most frequent FDA product codes are FMQ (Restraint, Protective, 14).
Has Heelbo, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Heelbo, Inc. Related entities may recall under other names.
Next steps
- See all 14 Heelbo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Heelbo, 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.