Empi: FDA clearances and approvals
Empi has 60 FDA 510(k) clearances (first 1977, latest 2010), across 10 product codes in 4 review panels. Median 510(k) review time: 76 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 17 | 17 |
| EGJ | Device, Iontophoresis, Other Uses | 11 | 11 |
| GXY | Electrode, Cutaneous | 10 | 10 |
| IPF | Stimulator, Muscle, Powered | 8 | 8 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 8 | 8 |
| HIR | Perineometer | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| GZI | Stimulator, Neuromuscular, External Functional | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Neurology (29)
- Physical Medicine (20)
- Gastroenterology and Urology (10)
- General and Plastic Surgery (1)
Most recent Empi 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093324 | EMPI CONTINUUM | IPF | 2010-03-05 | 133 |
| K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR | GZJ | 2009-06-05 | 65 |
| K072946 | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | EGJ | 2007-11-16 | 30 |
| K070427 | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | EGJ | 2007-05-14 | 90 |
| K061650 | SELECT TENS, MODEL 4600S | GZJ | 2007-01-22 | 223 |
| K041920 | INFINITY PLUS ELECTROTHERAPY SYSTEM | IPF | 2005-01-21 | 189 |
| K042057 | INFINITY ELECTROTHERAPY SYSTEM | LIH | 2004-12-17 | 140 |
| K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | EGJ | 2003-04-08 | 62 |
| K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | IPF | 2002-06-18 | 75 |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | EGJ | 1999-09-10 | 88 |
50 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Empi.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Empi's product codes (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances does Empi have?
Empi has 60 FDA 510(k) clearances (first 1977, latest 2010), across 10 product codes in 4 review panels.
How long does FDA take to clear Empi's 510(k)s?
The median time from FDA receipt to decision across Empi's cleared 510(k)s is 76 days.
What devices does Empi make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 17); EGJ (Device, Iontophoresis, Other Uses, 11); GXY (Electrode, Cutaneous, 10).
Has Empi had device recalls?
openFDA lists no recalls under a recalling firm name matching Empi. Related entities may recall under other names.
Next steps
- See all 60 Empi clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Empi'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.