FDA.report

CHATTANOOGA

Primary DI
00888912294232
Brand
CHATTANOOGA
Company
DJO, LLC
Model
2789
Device description
VECTRA GENISYS 4CH COMBO PKG US 5CM APPL
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GZISTIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Product Code Classifications

CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888912294232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912294232008889122942328889122942320888912294232

GMDN Terms

TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860011699309EvoWalkEvolution Devices, Inc.GZI2025-08-06
00810188050052L360 Thigh SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.GZI2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050236L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050250L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050267L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050281L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050298L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050304L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050311L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050328L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050335L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050359H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050366H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050373H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050380H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050397H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050403H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050410H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050427H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050434H200 Wireless SystemBioness Medical, Inc.GZI2025-07-17
00810188050595L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050601H200 WirelessBioness Medical, Inc.GZI2025-07-17
06976287180824Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.GZI2024-07-18
17540176030147ReGraspRehabtronics IncGZI2024-02-23