Djo, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Djo, LLC” (first 2009, latest 2020), plus 1 PMA decision, across 5 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Since 2017 the median was 83 days, against 138 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Enovis (DJO), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 63 |
| 2013 | 2 | 112 |
| 2014 | 1 | 261 |
| 2015 | 1 | 134 |
| 2016 | 3 | 113 |
| 2017 | 2 | 83 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 162 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Djo, LLC took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 4 | 4 |
| JOW | Sleeve, Limb, Compressible | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 1 | 0 |
Review panels
- Physical Medicine (8)
- Cardiovascular (3)
- Neurology (1)
- Orthopedic (1)
Most recent Djo, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201653 | Compex Sport Elite 3.0 | NGX | 2020-11-27 | 162 |
| K170918 | Compex Sport Elite | NGX | 2017-06-20 | 83 |
| K170903 | Compex Wireless USA | NGX | 2017-06-19 | 83 |
| K153704 | Strive | GZJ | 2016-06-03 | 163 |
| K153696 | Chattanooga Revolution Wireless | IPF | 2016-04-14 | 113 |
| K153224 | VitalStim(R) Plus Electrotherapy System | IPF | 2016-02-17 | 103 |
| K143551 | Compex Wireless USA | NGX | 2015-04-28 | 134 |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | IPF | 2014-04-10 | 261 |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | 2013-06-20 | 94 |
| K124016 | EMPI PHOENIX | IPF | 2013-05-06 | 130 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910066 | PMA | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | 1994-03-04 |
Recalls
11 product recalls in 7 recall events; 5 initiated in the last five years. Most recent: 2026-03-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Djo, LLC?
FDA lists 12 510(k) clearances under the applicant name “Djo, LLC” (first 2009, latest 2020), plus 1 PMA decision, across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Djo, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Djo, LLC is 108 days. Since 2017: 83 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Djo, LLC?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 4); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 4); JOW (Sleeve, Limb, Compressible, 3).
Next steps
- See all 12 Djo, LLC clearances with predicates and recalls
- Run predicate analysis for product code IPF, Djo, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.