FMA TRANSLATOR MANUFACTURED BY GREAT LAKES ORTHODONTICS, LTD.

Company Name	GREAT LAKES ORTHODONTICS, LTD.
Address	200 COOPER AVE.DR.
City, State / Province, ZIP / Postal Code	TONAWANDA, NY 14150
Country	US
FDA Owner/Operator Phone	800-828-7626
FDA Medical Specialty Code	PM - Physical Medicine
FDA Product Code	ISD
FDA Classification Name	EXERCISER, MEASURING
FDA Device Classification Code	Standards
FDA Regulation Number	890.5360
FDA Common Generic Name	EXERCISER PASSIVE MEASURING
FDA Proprietary Device Name	FMA TRANSLATOR
FDA Owner / Operator Number	1316408
FDA Owner / Operator Name	GREAT LAKES ORTHODONTICS, LTD.
FDA Establishment Registration Number	1316408
FDA Registered Establishment Name	GREAT LAKES ORTHODONTICS, LTD.
FDA Operation Code(s)	MP - Private Label Manufacturer

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

	Company Name	Proprietary Device Name	Common Generic Device Name
1	BIODEX MEDICAL SYSTEMS, INC.	BIODEX CYCLES	REHABILITATION BIKES AND CYCLES
2	BIOMETRICS LTD.	E-LINK UPPER LIMB EXERCISER, HAND KIT, E4000, H500	ACTIVE RESISTIVE EXERCISE, HAND STRENGTH EVALUATION
3	BTE TECHNOLOGIES, INC.	BTE WS30 (PRIMUS)	PHYSICAL MEDICINE THERAPEUTIC DEVICE
4	LODE B.V.	LODE	CUFF, EXERCISER, MEASURING
5	MEDX CORPORATION	MEDX96 LUMBAR EXTENSION MACHINE	LUMBAR EXTENSION
6	NORTH COAST MEDICAL, INC.	MULTIPLE	VARIOUS TYPES OF HAND CYCLES
7	SAEHAN CORPORATION	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
8	VIASYS HEALTHCARE GMBH	JAEGER UNIVERSAL-ERGOTEST	MEASURING EXERCISE EQUIPMENT