FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00888912268547
Brand
CHATTANOOGA
Company
DJO, LLC
Model
20660
Device description
KIT SG SHOULDER COM
Published
2022-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00888912268547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912268547008889122685478889122685470888912268547

GMDN Terms#

Term, Definition table
TermDefinition
Hip/knee continuous passive motion exerciserA mains electricity (AC-powered) device intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee, typically following joint surgery/trauma to promote healing; some types may also operate with patient assistance under controlled active motion (CAM). The device may stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and coordination training. It typically consists of a motorized carriage with straps to hold and move the leg/knee, and an electrical control unit for the healthcare professional to set the motion range/speed; digital displays and manual/automated safety capabilities may also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
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
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

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
00888912267588CHATTANOOGADJO, LLCBXB2026-03-31
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