SENSEWEAR ARMBAND MANUFACTURED BY ROCHE DIAGNOSTICS CORP.

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SENSEWEAR ARMBAND

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS CORP.
Address	9115 HAGUE RD.
City, State, Zip	INDIANAPOLIS, IN 46250
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	PM - Physical Medicine
FDA Product Code	IKK
FDA Classification Name	SYSTEM, ISOKINETIC TESTING AND EVALUATION
FDA Device Classification Code	Standards
FDA Regulation Number	890.1925
FDA Common Generic Name	ISOKINETIC ARMBAND
FDA Proprietary Device Name	SENSEWEAR ARMBAND
FDA Owner / Operator Number	1823260
FDA Owner / Operator Name	ROCHE HOLDING, INC.
FDA Establishment Registration Number	1823260
FDA Registered Establishment Name	ROCHE DIAGNOSTICS CORP.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	05-04-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS CORP.

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	BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. SHIRLEY, NY 11967 US 631-924-9000 / 631-924-9000 2343	MULTIPLE	VARIOUS ISOKINETIC EQUIPMENT
2	BODYMEDIA, INC. 4 SMITHFIELD ST. PITTSBURGH, PA 15222 US 412-288-9901 / 412-288-9901 1102	SENSEWEAR ARMBAND	ACTIVITY MONITOR
3	BTE TECHNOLOGIES, INC. 7455-L NEW RIDGE RD. HANOVER, MD 21076 US 410-850-0333 101 / 410-850-0333 101	MCU, ER, TEST, EVALUATOR, CIRES, EVAL TECH	PHYSICAL MEDICINE DIAGNOSTIC DEVICE
4	COMPUTER SPORTS MEDICINE, INC. 101 TOSCA DR. STOUGHTON, MA 02072 US 781-297-2034 / 781-297-2034 107	MULTIPLE	VARIOUS MODELS OF ISOKINETIC TESTING AND EVALUATION EQUIPMENT
5	CYMA CORPORATION 6405 218TH AVE. SW SUITE 100 MOUNTLAKE TERRACE, WA 98043 US 425-771-0797 / 425-771-0797	STEPWATCH	STEPWATCH ACTIVITY MONITOR
6	DJO, LLC 1430 DECISION STREET VISTA, CA 92081 US 760-727-1280 / 760-734-3122	DONJOY VISTA REHABILITATION MGMT SYSTEM	ISOKINETIC TESTING & EVALUATION SYSTEM
7	GUITAY S.A.M. CHEMIN SAINT HUBERT 5 SION, 1950 SZ 377-97-772050 / 678-908-8180	SPINEFORCE	REHABILITATIVE EXERCISE DEVICE
8	INTEGRITY PRACTICE MANAGEMENT, INC. 7501 E HIGHWAY 42 SIOUX FALLS, SD 57110 US / 605-728-1976	VARIOUS MODELS	VARIOUS MODELS
9	INTERACTIVE MOTION TECHNOLOGIES, INC. 37 SPINELLI PLACE CAMBRIDGE, MA 02138 US 617-497-6330 / 617-497-6330	IN MOTION 2	ROBOT THERAPIST
10	INTERACTIVE PERFORMANCE MONITORING, INC. (IPM) 1230 NE HICKMAN CT. PULLMAN, WA 99163 US 509-334-6363 / 509-332-4149	OMINIKINETIC	OMINIKINETIC
11	LPG SYSTEMS 30 RUE DU DOCTEUR ABEL VALENCE, 26902 FR / 786-473-4117	SPINEFORCE & HUBER	POWERED EXERCISE EQUIPMENT
12	MANUFACTURING TECHNOLOGY, INC. 70 READY AVE., N.W. FORT WALTON BEACH, FL 32548 US 850-664-6070 303 / 850-664-6070 303	MTI ACTIGRAPH, ACTIGRAPH ISOKINETIC TESTING SYSTEM	ACTIVITY MONITOR
13	MEDX CORPORATION 1401 N.E. 77TH ST. OCALA, FL 34479 US 352-622-2112 / 407-937-0047 132	MULTIPLE	VARIOUS
14	MOTORIKA MEDICAL (ISRAEL) LTD. 15 ALON HATAVOR ST. CAESAREA, ISRAEL, 38900 IS 972-462-75559 / 972-9-7670002	ARMSTRONG DEVICE	REHABILITATION EXERCISE DEVICE
15	NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD. MORGAN HILL, CA 95037 US 408-776-5000 / 408-776-5000 169	MULTIPLE	SENSORY MOTOR/PERCEPTUAL ACTIVITIES
16	PNEUMEX, INC. 2605 NORTH BOYER AVE. SANDPOINT, ID 83864 US 208-265-4105 / 208-265-4105 105	PNEU BACK CHAIR	BACK CHAIR
17	SAEHAN CORPORATION 973 YANGDUK-DONG MASAN, KYUNGSANGNAM-DO, 630-728 KS 82-55-2940381 / 931-937-8093	TENSIOMETER REPLACEMENT PARTS	PC2007, PC2010, PC201W, PC2011A, PC2012, VARIOUS TYPES & SIZES
18	SPINERX TECHNOLOGY 6100 BRITTMOORE RD., SUITE S HOUSTON, TX 77041 US 713-983-9979 / 713-983-0939	SPINERX LEM	LUMBAR EXTENSION MACHINE