Henley Intl.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Henley Intl.” (first 1986, latest 1995), across 18 product codes in 5 review panels. Median 510(k) review time under this name: 138 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 10 | 10 |
| GXY | Electrode, Cutaneous | 4 | 4 |
| ISD | Exerciser, Measuring | 4 | 4 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| GYB | Media, Electroconductive | 2 | 2 |
| IMF | Unit, Chilling | 2 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
Plus 8 more product codes.
Review panels
- Physical Medicine (22)
- Neurology (18)
- General Hospital (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Henley Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES | GXY | 1995-11-15 | 485 |
| K926279 | UPPER BODY EXERCISER | ISD | 1994-05-05 | 507 |
| K926278 | STAIR CLIMBER | ISD | 1994-05-05 | 507 |
| K926287 | EXERCISE BICYCLE | ISD | 1994-03-22 | 463 |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | ISD | 1994-03-18 | 458 |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | BXB | 1994-02-04 | 416 |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | GXY | 1993-07-21 | 568 |
| K922036 | SONOPULS 591 | IMG | 1993-06-29 | 424 |
| K926316 | TRUE-TRAC, STRATUS | JFB | 1993-03-24 | 99 |
| K920983 | SONOPULS 590 | IMI | 1993-03-09 | 372 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Henley Intl..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Henley Healthcare, Inc. (2 510(k)s)
- Henley Board, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Henley Intl.?
FDA lists 44 510(k) clearances under the applicant name “Henley Intl.” (first 1986, latest 1995), across 18 product codes in 5 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 Henley Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Henley Intl. is 138 days.
Which FDA product codes appear under Henley Intl.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 10); GXY (Electrode, Cutaneous, 4); ISD (Exerciser, Measuring, 4).
Next steps
- See all 44 Henley Intl. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Henley Intl.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.