VARIOUS ELECTRICAL STIMULATOR UNITS MANUFACTURED BY GYRUS ACMI L.P.

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VARIOUS ELECTRICAL STIMULATOR UNITS

Request for Information Form	Contact Information
Company Name	GYRUS ACMI L.P.
Address	6845 WEDGEWOOD RD.
City, State, Zip	MAPLE GROVE, MN 55311
Country	US
FDA Owner/Operator Phone	011-44-189219750
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	KPI
FDA Classification Name	STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
FDA Device Classification Code	Standards
FDA Regulation Number	876.5320
FDA Common Generic Name	STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
FDA Proprietary Device Name	VARIOUS ELECTRICAL STIMULATOR UNITS
FDA Owner / Operator Number	9018965
FDA Owner / Operator Name	GYRUS GROUP PLC
FDA Establishment Registration Number	117977
FDA Registered Establishment Name	GYRUS ACMI L.P.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-27-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of GYRUS ACMI L.P.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ADAMED LTD. PIENKOW 149 CZOSNOW, 05-152 PL 048-22-7518517 / 48-22-732 77 37	KOLPEXIN-T	KOLPEXIN-T
2	ATHENA FEMININE TECHNOLOGIES, INC. 179 MORAGA WAY ORINDA, CA 94563 US 925-254-6090 / 925-254-6090	ATHENA PELVIC MUSCLE TRAINER	PELVIC MUSCLE TRAINER, ELECTRICAL STIMULATOR
3	AVAZZIA, INC. 13154 COIT RD., STE. 200 DALLAS, TX 75240 US 214-575-2820 / 214-575-2820	SKYLARK URO PROBE 51 AND 52	INCONTINENCE PROBE
4	BOW WINDOW SKYLARK TECHNOLOGIES DEVELOPMENT CO., L 2F-4,40-2,SEC. 1 MING SHEN N. ROAD TAOYUAN, TW 886-2-2597 9001 / 886-3-3587677	INCONTINENCE TREATMENT SYSTEM	ELECTRICAL STIMULATION SYSTEM FOR INCONTINENCE
5	CIMETRA LLC. 8396 STATE ROUTE 9 WEST CHAZY, NY 12992 US 518-846-7606 / 518-846-7606	MYOTRAC INFINITI SYSTEM	NON-IMPLANTED ELECTRICAL CONTINENCE DEVICE
6	DANMETER A/S KILDEMOSEVEJ 13 ODENSE C, DK-5000 DA 45-631-1 29 30 / 45-631-1 29 30	ELPHA 4 CONTI	ELPHA, MODEL 4 CONTI
7	EMC (ELECTROFORMING MEDICAL CONCEPT) Z.I. DE FELET THIERS, 63300 FR 330-473-806652 / 802-878-1110 114	STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE)	STIMULATION/BIOFEEDBACK PROBES
8	EMPI 599 CARDIGAN RD. ST. PAUL, MN 55126 US 651-415-7469 / 651-415-7469	INNOVA INCONTINENCE TREATMENT SYSTEM	ELECTRICAL STIMULATION SYSTEM FOR INCONTINENCE
9	HOLLISTER, INC. 366 DRAFT AVE. STUARTS DRAFT, VA 24477 US 847-680-1000 / 847-680-2849	MULTIPLE	PELVIC FLOOR MUSCLE REHABILITATION SYSTEM AND PROBES
10	HOLLISTER, INC. 520 BRICK CHURCH PARK DR. NASHVILLE, TN 37207 US 847-680-1000 / 847-680-2849	INCARE PELVIC FLOOR THERAPY SYSTEM AND STIM/EMG PROBES	PELVIC FLOOR MUSCLE REHABILITATION SYSTEM AND PROBES
11	INNOVAMED USA, INC. 1103 EAST LEELAND HTS. BLVD. LEHIGH ACRES, FL 33936 US 941-368-7767 / 239-368-7767	DETRUSAN 500	INCONTINENCE-DEVICE
12	KING CHAMPION INDUSTRIES, LTD. UNIT 804, 8/F, 9 WING HONG ST. KOWLOON, HK / 925-254-6090	ATHENA PELVIC MUSCLE TRAINER	PELVIC MUSCLE TRAINER, ELECTRICAL STIMULATOR
13	LABORIE MEDICAL TECHNOLOGIES, INC. 6415 NORTHWEST DR., UNIT 11 MISSISSAUGA, L4V 1X1 CA 31-053-4340902 / 802-857-1300	UROSTYM BIOFEED BACK AND STIMULATION PROBES	NON-IMPLANTABLE BIOFEED BACK & STIMULATOR
14	NEOTONUS, INC. 30 SOUTH PARK SQ, STE 201 MARIETTA, GA 30060 US 770-428-7356 / 678-784-5113	NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM	PELVIC FLOOR STIMULATOR
15	THE PROMETHEUS GROUP 1 WASHINGTON ST., SUITE 303 DOVER, NH 03820 US 800-442-2325 / 603-749-0733	PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM	PELVIC FLOOR TRAINING SYSTEM
16	THOUGHT TECHNOLOGY LTD. 8205 MONTREAL/TORONTO BLVD., SUITE 223 MONTREAL WEST, QUEBEC, H4X 1N1 CA 514-489-8251 / 514-489-8251	MYOTRAC INFINITI SYSTEM	NON IMPLANTED ELECTRICAL CONTINENCE DEVICE
17	UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST MIDVALE, UT 84047 US 801-566-1200 / 801-566-1200 4039	LIBERTY INTERVAGINAL PELVIC FLOOR STIMULATOR	PELVIC FLOOR STIMULATOR