FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00888912267588
Brand
CHATTANOOGA
Company
DJO, LLC
Model
2025
Device description
OPTIFLEX K1 STANDARD
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BXBEXERCISER, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912267588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912267588008889122675888889122675880888912267588

GMDN Terms#

Term, Definition table
TermDefinition
Continuous passive motion joint exerciserA mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31
00190446968344DJO SURGICALS-2019632026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
06976287180787Active Passive Trainer for Upper and Lower LimbsGuangzhou Longest Medical Technology Co., Ltd.BXB2026-04-14
00888912267618CHATTANOOGADJO, LLCBXB2026-03-31
00888912267625CHATTANOOGADJO, LLCBXB2026-03-31
00888912267632CHATTANOOGADJO, LLCBXB2026-03-31
04041925006230THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
04041925006247THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
09120077180212AMADEOtyromotion GmbHBXB2026-03-12
09120077180236DIEGOtyromotion GmbHBXB2026-03-12
09120077180243OMEGOtyromotion GmbHBXB2026-03-12
04041925006254THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-12-16
04041925006261THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006278THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006285THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006308OmniCycle® Revo medica - Medizintechnik GmbHBXB2025-12-16
04041925006315OmniCycle® Revomedica - Medizintechnik GmbHBXB2025-12-16
EJKP100004088A0Recovery 7200 PFJK-Products GmbHBXB2025-12-10
EJKP100004192A0Red Wave Recovery JK-Products GmbHBXB2025-10-30
00860005350827AMBLENextstep Robotics, Inc.BXB2025-09-29
04041925006193THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-09-04
04041925006179THERA-Trainer tigomedica - Medizintechnik GmbHBXB2025-08-28
06977069490001Handheld Direct Drive Cable TrainerBeyond Power Inc.BXB2025-08-07