FDA 510(k) Applications for Medical Device:
Stimulator, Electrical, Non-Implantable, For Incontinence
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093600 | ACCELERATED CARE PLUS |
4850 JOULE ST, STE A-1 | RENO | NV | 89502 |
| K023905 | ATHENA FEMININE TECHNOLOGIES, INC. |
179 MORAGA WAY | ORINDA | CA | 92520 |
| K033256 | ATHENA FEMININE TECHNOLOGIES, INC. |
179 MORAGA WAY | ORINDA | CA | 94563-3442 |
| K162010 | BTL Industries, Inc. |
47 Loring Drive | Framingham | MA | 01702 |
| K181497 | BTL Industries, Inc. |
362 Elm Street | Marlborough | MA | 01752 |
| K964738 | DAN MED, INC. |
4450 ARAPAHOE AVE. | BOULDER | CO | 80303 |
| K032988 | DANMETER A/S |
KILDEMOSEVEJ 13 | ODENSE C | DK-5000 | |
| K002154 | EMD ELECTRONIC MEDICAL DEVICES, CORP. |
1621 BAY ROAD, SUITE 908 | MIAMI BEACH | FL | 33139-3260 |
| K971527 | EMPI |
599 CARDIGAN RD. | ST. PAUL | MN | 55126 |
| K964577 | EMPI |
599 CARDIGAN RD. | ST. PAUL | MN | 55126 |
| K972054 | EMPI |
599 CARDIGAN RD. | ST. PAUL | MN | 55126 |
| K954272 | EMPI |
5255 EAST RIVER RD. | MINNEAPOLIS | MN | 55421 |
| K970307 | EMPI |
599 CARDIGAN RD. | ST. PAUL | MN | 55126 |
| K983206 | EMPI |
599 CARDIGAN RD. | ST. PAUL | MN | 55126 |
| K161349 | EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
3FL., NO. 5, LANE 155, SECTION 3, | SHENKENG DIST, NEW TAIPEI CITY | 22203 | |
| K213116 | Everyway Medical Instruments Co., Ltd. |
3FL., No. 5, Lane 155, Section 3, Beishen Rd., | Shenkeng District, New Taipei City | 22203 | |
| K122194 | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
3 FL., NO. 5, LANE 155, SEC.3, | SHEN KENG HSIANG,TAIPEI HSIEN | 222 | |
| K161055 | Fuji Dynamics Ltd |
1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road | Hong Kong | ||
| K140265 | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD, | SHENZHEN | 518000 | |
| K142369 | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
F19, NO. 1 KESHENG ROAD, BAIYUN TORCH, BUILDING, NO. 1633 | GUANGZHOU | 510040 | |
| K011435 | HMT, INC. |
3/4 FL. HAK BLDG. 249-13 | SEOUL | 137-130 | |
| K990456 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K050483 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K961872 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K974048 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K013141 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963222 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K971541 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K970602 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K141158 | INCONTROL MEDICAL, LLC |
3225 GATEWAY ROAD, SUITE 250 | BROOKFIELD | WI | 53045 |
| K150183 | InControl Medical, LLC |
3225 Gateway Road, Ste. 250 | Brookfield | WI | 53045 |
| K182022 | InControl Medical, LLC |
3225 Gateway Road Suite 250 | Brookfield | WI | 53045 |
| K110179 | INCONTROL MEDICAL, LLC |
12715 FALCON DRIVE | BROOKFIELD | WI | 53005 |
| K133826 | INCONTROL MEDICAL, LLC |
3225 GATEWAY ROAD, SUITE 250 | BROOKFIELD | WI | 53045 |
| K134020 | INCONTROL MEDICAL, LLC |
3225 GATEWAY ROAD, SUITE 250 | BROOKFIELD | WI | 53045 |
| K150180 | INCONTROL MEDICAL, LLC. |
3225 GATEWAY ROAD, STE. 250 | BROOKFIELD | WI | 53045 |
| K200293 | InMode Ltd. |
Tabor Building, Shaar Yokneam | Yoqneam Illit | 2069200 | |
| K994109 | INNOVAMED USA, INC. |
1140 LEE BLVD., SUITE 101-103 | LEHIGH ACRES | FL | 33936 |
| K141643 | INTERNATIONAL TRADE GROUP, INC. |
4663 KATIE LN. | OXFORD | OH | 45056 |
| K160773 | INTERNATIONAL TRADE GROUP, INC. |
4663 KATIE LANE | OXFORD | OH | 45056 |
| K993721 | LABORIE MEDICAL TECH CORP. |
310 HURRICANE LN. #2 | WILLISTON | VT | 05495 |
| K990041 | LABORIE MEDICAL TECH CORP. |
310 HURRICANE LN. #2 | WILLISTON | VT | 05495 |
| K070331 | LABORIE MEDICAL TECHNOLOGIES |
400 AVENUE D SUITE 10 | WILLISTON | VT | 05495 |
| K962009 | LABORIE MEDICAL TECHNOLOGIES, LTD. |
7 GREEN TREE DR. | SOUTH BURLINGTON | VT | 05403 |
| K230767 | Nanjing Vishee Medical Technology Co., Ltd. |
Building 9, No.19, Ningshuang Road, Yuhuatai District | Nanjing | 210012 | |
| K081480 | NE SERVICES LTD. |
4663 KATE LANE | OXFORD | OH | 45056 |
| K001903 | NEOTONUS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K973096 | NEOTONUS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K213133 | Oriental Inspiration Limited |
Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre, | Hong Kong | ||
| K171430 | Shenzhen Dongdixin Technology Co., Ltd |
No. 3 Building, XiLiBaimang Xusheng Industrial Estate | Shenzhen | 518108 | |
| K163288 | Shenzhen Konmed Technology Co., Ltd. |
703B, Haide building A, Nanxin Road, Nanshan | Shenzhen | 518000 | |
| K220161 | Shenzhen Konmed Technology Co.,Ltd. |
601, Building B4, Shenchengtou Creative Factory Life | Shenzhen | 518118 | |
| K210441 | Shenzhen Med-link Electronics Tech Co, Ltd |
4th And 5th Floor, Building Two, Hualian Industrial Zone, | Shenzhen | 518109 | |
| K053007 | SKYLARK DEVICE & SYSTEMS CO., LTD |
4F, 34, SEC. 3, | TAIPEI | 104 | |
| K191312 | TensCare Ltd. |
9 Blenheim Road, Longmead Business Park | Epsom | KT19 9BE | |
| K103698 | TENSCARE LTD. |
9 BLENHEIM ROAD | EPSOM, SURREY | KT19 9BE | |
| K142506 | TENSCARE LTD. |
9 BLENHEIM ROAD | EPSOM | KT19 9BE | |
| K001515 | THE PROMETHEUS GROUP |
2 MALLARDS COVE | DUXBURY | MA | 02332 |
| K023906 | THE PROMETHEUS GROUP |
1 WASHINGTON ST., SUITE 303 | DOVER | NH | 03820 |
| K030039 | THE PROMETHEUS GROUP |
2 MALLARDS COVE | DUXBURY | MA | 02332 |
| K993976 | THE PROMETHEUS GROUP |
2 MALLARDS COVE | DUXBURY | MA | 02332 |
| K201014 | Thought Technology LTD. |
5250 Ferrier, Suite 812 | Montreal | H4P 1L3 | |
| K053434 | THOUGHT TECHNOLOGY LTD. |
2180 BELGRAVE AVE. | MONTREAL, QUEBEC | H4A 2LB | |
| K960496 | UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST | MIDVALE | UT | 84047-1048 |
| K970077 | UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST | MIDVALE | UT | 84047-1048 |
| K964526 | UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST | MIDVALE | UT | 84047-1048 |
| K083704 | VERITY SCIENTIFIC LTD. |
4663 KATE LANE | OXFORD | OH | 45056 |
| K222528 | Well-Life Healthcare Limited |
6F., No. 168. de St., Jhonghe District | New Taipei City | 235 | |
| K230780 | Zimmer MedizinSysteme GmbH |
Junkersstrasse 9 | Neu-Ulm | 89231 | |
| K121820 | ZYNEX MEDICAL, INC. |
9990 Park Meadows Dr. | Lone Tree | CO | 80124 |
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