# Bio-Medical Research, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 37 (1984–2021): 36 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Bio-Medical Research, Ltd. (32); Bio-Medical Research Corp. (5)
- Product codes: NGX (15), GZJ (10), IPF (7), GXY (3), NFO (1), QAJ (1)
- 510(k) review time since 2016: median 106 days, against 240 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 45 (33 its own); citations of its devices by later devices: 60 (33 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Skylark Device Co., Ltd.: 2 (https://510kreport.com/company/skylark-device)
- Compex Technologies, Inc.: 2 (https://510kreport.com/company/compex-technologies)
- Murray Electronics: 2 (https://510kreport.com/company/murray-electronics)
- Salton, Inc.: 1 (https://510kreport.com/company/salton)
- Empi: 1 (https://510kreport.com/company/empi)
- Djo, LLC: 1 (https://510kreport.com/company/djo)
- Axelgaard Mfg. Co., Ltd.: 1 (https://510kreport.com/company/axelgaard-mfg)
- Staodyne, Inc.: 1 (https://510kreport.com/company/staodyne)

## Firms that cite its devices most
- Sport-Elec: 4 (https://510kreport.com/company/sport-elec)
- Gemore Technology Co, Ltd.: 2 (https://510kreport.com/company/gemore-technology)
- Well-Life Healthcare Limited: 2 (https://510kreport.com/company/well-life-healthcare)
- The Dezac Group: 2 (https://510kreport.com/company/dezac-group)
- Cymedica Orthopedics, Inc.: 2 (https://510kreport.com/company/cymedica-orthopedics)
- Elidah, Inc.: 1 (https://510kreport.com/company/elidah)
- Shenzhen Qianyu Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-qianyu-technology)
- Global Marketing Partners Dba Gymmax USA: 1 (https://510kreport.com/company/global-marketing-partners-dba-gymmax-usa)

## Its most-cited devices
- K010335: Slendertone Flex, Model, 512 (2001), cited by 9
- K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20 (2007), cited by 6
- K030708: Slendertone Flex Abdominal Training System, Type 515 (2003), cited by 6
- K082011: Medistim XP, Type 281 and Meditens XP, Type 458 (2008), cited by 4
- K083105: Kneehab XP Conductive Garment, Type 411 (2009), cited by 4
- K071666: Slendertone Enervive, Model 561 (2008), cited by 4

## Recent decisions
- K203513: SLENDERTONE Evolve Abs, Type 735 (Feb 10, 2021)
- DEN170049: Innovo (Nov 6, 2018)
- K180688: SLENDERTONE CoreFit Abs 8, Type 734 (Oct 25, 2018)
- K161974: SLENDERTONE® Connect Abs, Type 570 (Nov 1, 2016)
- K151903: Slendertone connect Abs (Nov 6, 2015)
- K112934: Neurotech Recovery (Jan 20, 2012)
- K112258: Neurotech Plus (Jan 9, 2012)
- K103031: BMR Face (Nov 10, 2011)

Source page: https://510kreport.com/company/bio-medical-research