FDA.reportPublic FDA data

gSource

Primary DI
M7557421900
Brand
gSource
Company
GSOURCE LLC
Model
gS 74.2190
Catalog number
gS 74.2190
Device description
Goniometer (Polk Finger) 6" Graduated cm/inch
Published
2020-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KQWGoniometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7557421900PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual goniometerA non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314263261gSourcegS 86.7506gS 86.75062026-07-24
00840314263278gSourcegS 86.7516gS 86.75162026-07-24
00840314263285gSourcegS 86.7571gS 86.75712026-07-24
00840314263353gSourcegS 86.7581gS 86.75812026-07-24
00840314263421gSourcegS 86.7591gS 86.75912026-07-24
00840314263704gSourcegS 86.9401gS 86.94012026-07-24
00840314263773gSourcegS 86.9451gS 86.94512026-07-24
00840314263841gSourcegS 86.9461gS 86.94612026-07-24
00840314233066gSourcegS 65.7431gS 65.74312020-02-18
00840314263636gSourcegS 86.9391gS 86.93912026-07-17
00840314264190gSourcegS 86.9521gS 86.95212026-07-17
00840314264268gSourcegS 86.9531gS 86.95312026-07-17
00840314264404gSourcegS 86.9551gS 86.95512026-07-17
00840314264473gSourcegS 86.9561gS 86.95612026-07-17
00840314264541gSourcegS 86.9571gS 86.95712026-07-17
00840314264619gSourcegS 86.9581gS 86.95812026-07-17
00840314264688gSourcegS 86.9591gS 86.95912026-07-17
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706842mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706859mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706866mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706873mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706880mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706897mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024694286mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694316mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694323mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694330mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024680708mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680739mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680746mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680753mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
10889981319908Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319915Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319922Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
G586G95549410Novo SurgicalNOVO SURGICAL, INC.KQW2023-12-18
00087453152104JamarHYGENIC CORPORATION, THEKQW2023-12-07
10885914030445JamarHYGENIC CORPORATION, THEKQW2023-12-07
00887868581120mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581151mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581168mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581175mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00816271020780myoRESEARCHNoraxon U.S.A., Inc.KQW2023-06-07
00860003118344CanarE – Clinic Wearable DeviceCanary Medical USA LLCKQW2023-05-17
00842962122624HNM MEDICALHNM STAINLESS, LLC.KQW2023-03-29
00887868574283mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574290mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574306mymobility® PlatformZimmer Us, Inc.KQW2023-03-16