FDA.reportPublic FDA data

Procomp 5 Encoder

Primary DI
07540191000043
Brand
Procomp 5 Encoder
Company
Thought Technology Ltd.
Model
SA7525
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903497000FLEXCOMP DSP & PROCOMPThought Technology , Ltd.1991-02-12HCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540191000043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540191000043075401910000437540191000043

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
209284132
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540191000494Myotrac 3 UnitSA99002019-10-29
07540191000067U-Control 60Hz Unit TTSA88252017-08-31
07540191000425Vaginal Sensor Unit TTLSA60502017-08-31
07540191000432Rectal Sensor Unit TTLSA60512017-08-31
07540191000647BioGraph Infiniti Advanced ReportingSA7900AR2024-12-12
07540191000630Resilience – By Inner Armor App iOSSA45152024-04-09
07540191000586MyOnyx Mobile AppSA90302023-06-07
07540191000593MyOnyx SA90202023-06-07
07540191000623eVu Senz App iOSSA45202022-05-06
07540191000609Pressure SensorSA90032022-03-23
07540191000616Vaginal Pressure ProbeSA90052022-03-23
07540191000555MyOnyxSA90002020-07-16
07540191000562NEUROINFINITI 2SA79042020-07-16
07540191000548MyOnyx Mobile AppSA90132019-11-01
07540191000487eVu Senz AppSA45022019-10-29
07540191000500Reverse Temp Sensor, GSR2PPSA2090M2019-10-29
07540191000517Remote Electrodes, GSR2 PPSA2050M2019-10-29
07540191000524GSR2 Unit Protected PinSA2000M2019-10-29
07540191000531Dual Sensitivity MeterSA20762019-10-29
07540191000012Myotrac 4000 60Hz Unit PPSA4000P2017-08-31

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04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
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