Bio-Medical Research, Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Bio-Medical Research, Ltd.” (first 1996, latest 2021), plus 1 De Novo decision, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 157 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 | 2 | 133 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 119 |
| 2016 | 1 | 106 |
| 2017 | 0 | — |
| 2018 | 1 | 224 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 72 |
| 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 Bio-Medical Research, Ltd. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 13 | 13 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 | 10 |
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| GXY | Electrode, Cutaneous | 3 | 3 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | 1 | 0 |
Review panels
- Physical Medicine (17)
- Neurology (14)
- Gastroenterology and Urology (1)
Most recent Bio-Medical Research, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203513 | SLENDERTONE Evolve Abs, Type 735 | NGX | 2021-02-10 | 72 |
| K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | NGX | 2018-10-25 | 224 |
| K161974 | SLENDERTONE® Connect Abs, Type 570 | NGX | 2016-11-01 | 106 |
| K151903 | Slendertone connect Abs | NGX | 2015-11-06 | 119 |
| K112934 | NEUROTECH RECOVERY | GXY | 2012-01-20 | 109 |
| K112258 | NEUROTECH PLUS | GZJ | 2012-01-09 | 157 |
| K103031 | BMR FACE | NFO | 2011-11-10 | 394 |
| K110350 | KNEEHAB XP | GZJ | 2011-08-03 | 177 |
| K102614 | AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 | GXY | 2011-06-03 | 266 |
| K100556 | SLENDERTONE FLEX MAX, MODEL 517 US | NGX | 2010-08-02 | 154 |
21 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170049 | De Novo | Cutaneous Electrode Stimulator For Urinary Incontinence | 2018-11-06 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Medical Research, Ltd..
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.
Device clinical trials
An industry sponsor named Bio-Medical Research, Ltd. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01740440: Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance (Completed, started 2012-11)
- NCT01632748: Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation (Completed, started 2012-06)
- NCT01614730: User Evaluation in Healthy Volunteers to Verify no Pelvic Floor Contraction is Stimulated When the Modified Neurotech Vital Device is Used Compared to the Neurotech Vital Device (Completed, started 2012-06)
- NCT01472068: A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence (Completed, started 2011-12)
- NCT01096524: Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty (Completed, started 2010-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Medical Research, Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Bio-Medical Research, Ltd.” (first 1996, latest 2021), plus 1 De Novo decision, across 6 product codes in 3 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 Bio-Medical Research, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Medical Research, Ltd. is 157 days.
Which FDA product codes appear under Bio-Medical Research, Ltd.?
The most frequent FDA product codes under this applicant name are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 13); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 10); IPF (Stimulator, Muscle, Powered, 4).
Next steps
- See all 31 Bio-Medical Research, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGX, Bio-Medical Research, Ltd.'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.