FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216105645
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
7507
Device description
DELUXE SMALL JOINT GONIOMETER
Published
2022-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840216105645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216105645008402161056458402161056450840216105645

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

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

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