BLUE HAND - 3" round, cloth, 1 pouch(2 pcs per pouch)
2026-07-07
BIO PROTECH USA, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004464672 | 3004464672 | BIO PROTECH USA, INC. | 1 | Y | 2026-01-01 | 13311 166th St Ste A Cerritos CA US 90703 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 93813 | 1133743748 | K153019 | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes | GXY | 2016-03-21 |
| 93813 | 1368370118 | K143103 | PROPENCIL Smoke Pencil | GEI | 2015-07-16 |
| 93813 | 1921171370 | K111270 | REUSABLE STIMULATING ELECTRODES | GXY | 2011-09-13 |
| 93813 | 1111809873 | K100246 | MAX-IF1000 | LIH | 2010-11-24 |
| 93813 | 1404639992 | K092761 | PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C | GEI | 2009-11-24 |
| 93813 | 1300548087 | K092732 | PROPENCIL ESU PENCIL | GEI | 2009-11-25 |
| 93813 | 1172912699 | K091248 | MAXEMS, MODELS 1000 AND 2000 | IPF | 2009-11-30 |
| 93813 | 1525668702 | K083148 | TELECTRODE WET GEL ECG ELECTRODE | DRX | 2008-11-07 |
| 93813 | 1366387053 | K073438 | PROSTIM 1000/2000 | GZJ | 2008-02-07 |
| 93813 | 1552295369 | K073360 | PROPLATE | GEI | 2007-12-19 |
| 93813 | 1409253925 | K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | DRX | 2005-12-14 |
| 93813 | 1037107126 | K042301 | PROTENS ELECTRODE | GXY | 2004-09-03 |
| 93813 | 1593782101 | K040784 | PROTAB ECG TABB ELECTRODE | DRX | 2004-04-07 |
| 93813 | 1831192159 | K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE | DRX | 2002-11-07 |
Product Codes Associated With Registrations#
GUDID#
BLUE HAND - 1.5"x1.5" sq., foam, 1 pouch(2 pairs per pouch)
2026-07-07
BLUE HAND - 1.5" round, foam, 1 pouch(2 pairs per pouch)
2026-07-07
BLUE HAND - 2" round, foam, 1 pouch(2 pairs per pouch)
2026-07-07
BLUE HAND - 2"x2" sq., foam, 1 pouch(2 pairs per pouch)
2026-07-07
BLUE HAND - 2"x4" rect., foam, 1 pouch(2 pcs per pouch)
2026-07-07
BLUE HAND - 3" round, foam, 1 pouch(2 pcs per pouch)
2026-07-07
BLUE HAND - 1.5"x1.5" sq., cloth, 1 pouch(2 pairs per pouch)
2026-07-07
Bio Protech - Generic (4848WCBZGN (48x48 sq. white cloth, NSCNS 35mil), 40pcs/PKG (no zipper)
2026-05-07
Bio Protech - Generic (4848WCBZGN (48x48 sq. white cloth, NSCNS 35mil), 20 pcs/1 poly, No zipper
2016-06-15
Bio Protech - 4848WCBZGN(NST) - 48mmx48mm Square Electrodes, White Fabric, Carbon, Plastic Zip Lock
2016-06-21
Bio Protech - SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel. 4 pcs per pack, 100 pcs per box, 1,000 pcs per case
2017-08-09
Bio Protech - SG15G (Lifelines) - Lifelines OEM, Surface Electrodes, Square Shape, Ground Electrode, Cloth Backing, 42x60mm, Hydrogel. 1pc per pack, 25 pcs per box, 250 pcs per case
2017-08-09
Bio Protech - NCS-1334 (Lifelines) - Lifelines OEM, Surface Electrodes, NCS Surface Electrode, Tabs, PET Film Backing Material, 13x24mm, Hydrogel, 100 pcs per pack, 500 pcs per box, 5,000 pcs per case
2017-08-09
Bio Protech - NCS-SG15 (Lifelines) - Lifelines OEM, Surface Electrodes, Trio Electrode, Round Shape, Cloth Backing Material, 22x22mm, Hydrogel, 3 pcs per pack, 75 pcs per box, 750 pcs per case
2017-08-09
Bio Protech - MF2409 (Lifelines) - Lifelines OEM, Surface Electrodes, Ring Electrode, PET Film Backing Material, 8x107mm, Hydrogel, 10 pcs per pack, 100 pcs per box, 1,000 pcs per case
2017-08-09
Bio Protech - MaxTens 1k - Analog Tens Unit
2016-06-15
Bio Protech - MaxEMS 1k - Analog EMS Unit
2016-06-16
Bio Protech - MaxEMS 2k - Digital EMS Unit
2016-06-17
Bio Protech - MaxTens 1k - Analog Tens Unit, with Black Carrying Case
2016-09-01
Bio Protech - MaxTens 2k - Digital Tens Unit
2016-06-16
Bio Protech - DEEG-A-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use
2017-08-09
Bio Protech - DEEG-A-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use
2017-08-09
Bio Protech - DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use
2017-08-09
Bio Protech - DEEG-A-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use
2017-08-09
Bio Protech - RGEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RGEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RGEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RSEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RSEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RSEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RSEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - RSEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups
2017-08-09
Bio Protech - P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (1pc per pouch, 25pc per box, 8box per case)
2017-06-06
Bio Protech - Saebo TENS Large Electrode (3pc/Pouch) - Each
2021-04-06
Bio Protech - Saebo TENS Small Electrode (3pc/Pouch) - Each
2021-04-06
Bio Protech - 30RdWCBZ(NST) - 30mm Round, White Fabric, Carbon, Plastic Zip Lock
2016-06-17
Bio Protech - 4848BCAZ(BLUE)- 48mmx48mm Square, Blue Fabric, Carbon, Blue Gel, Plastic Zip Lock
2016-06-17