FDA.reportPublic FDA data

One Button Response Unit

Primary DI
07290103039073
Brand
One Button Response Unit
Company
MEDOC LTD.
Model
OBRU
Catalog number
DT 00012
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRWDynamometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRWDynamometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103039073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103039073072901030390737290103039073

GMDN Terms#

Term, Definition table
TermDefinition
Pressure algometer/aesthesiometer, electronicAn electrically-powered digital instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force (pressure) to the skin; and 2) tactile sensibility (two-point touch discrimination) by application of a thin filament(s) to the skin. It is a hand-held device with a thin filament(s) with a pre-set flexibility intended to apply a known pressure (e.g., two-point aesthesiometer). It is typically used during diagnosis or treatment of nerve injuries and neuropathies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600469191
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103039011Medoc Main Station SoftwareMMSSW 000122023-06-20
07290103039066CoVasCoVasAS 002132023-06-20
07290103039219 Thermode CHEPSTSA 2AS 004202023-06-20
07290103039233Q-Sense Response UnitQ-SenseAS 004032023-06-20
07290103039240Q-Sense Base AssemblyQ-SenseAS 004002023-06-20
07290103039264Patient Response UnitPRUAS 002432023-06-20
07290103039653VSA 2 Hand HeldVSA 2MO 000172023-06-20
07290103039660VSA 2 Handheld deviceVSA 2 Handheld DeviceAS 004222023-06-20
07290103039677VSA 2 Hand-Leg supportVSA 2 Leg AS 004252023-06-20
07290103039820TSA 2 Air TSA 2 Air 2023-06-20
07290103039837TSA 2 Air TSA 2 Air AS 001892023-06-20
07290103039899TSA 2TSA 2AS 001702023-06-20
07290103039905TSA 2TSA 2MO 000152023-06-20
07290103039912Thermode 30X30 (TSA 2) TSA 2 30X30AS 001762023-06-20
07290103039929Thermode 16X16 (TSA 2) Thermode 16X16AS 001772023-06-20
07290103039936Thermode fMRI 30*30mm - including fMRI filterThermode fMRIAS 001782023-06-20
07290103039943Thermode fMRI 16X16mm - including fMRI filterfMRI ThermodeAS 001792023-06-20
07290103039950Thermode CHEPS fMRI CHEPSAS 004212023-06-20
07290103039967Thermode 6mm diameterTSA 2AS 001852023-06-20
07290103039974Thermode 30x30mm (Q-Sense)Q-SenseAS 004022023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809513720052SAEHAN Squeeze DynamometerSaehan CorporationHRW2026-05-18
08809513720076Spring Hand DynamometerSaehan CorporationHRW2026-05-18
08809513720380Back-Leg-Chest DynamometerSaehan CorporationHRW2026-05-18
04719846012660CharderCHARDER ELECTRONIC CO., LTD.HRW2026-04-29
04719846017030CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
14719846017037CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
08033390301848General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301855General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301862General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301879General InstrumentLIMACORPORATE SPAHRW2025-06-10
00855170007423DualGrip Digital Grip DynamometerLAFAYETTE INSTRUMENT COMPANY, INC.HRW2024-09-11
08033390237734PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390237741PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390109499NALIMACORPORATE SPAHRW2022-09-08
08033390196123NALIMACORPORATE SPAHRW2022-09-08
00840216112728JAMARAsp Global, LLCHRW2022-08-09
00840216112735JAMARAsp Global, LLCHRW2022-08-09
00840216112704JAMARAsp Global, LLCHRW2022-04-27
00840216112667JAMARAsp Global, LLCHRW2022-04-04
00840216112650JAMARAsp Global, LLCHRW2022-03-18
00840216112674JAMARAsp Global, LLCHRW2022-03-18
00840216112681JAMARAsp Global, LLCHRW2022-03-18
00840216112698JAMARAsp Global, LLCHRW2022-03-18
00840216112711JAMARAsp Global, LLCHRW2022-03-18
00840216112742JAMARAsp Global, LLCHRW2022-03-18
00840216112759JAMARAsp Global, LLCHRW2022-03-18
00840216112766JAMARAsp Global, LLCHRW2022-03-18
00840216112773JAMARAsp Global, LLCHRW2022-03-18
00855170007119Professional Hand Evaluation KitLAFAYETTE INSTRUMENT COMPANY, INC.HRW2021-08-31