FDA.reportPublic FDA data

Circulating-fluid thermal/compression therapy system wrap

Definition
A non-sterile component of a circulating-fluid thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.
GUDID devices
168
Last updated
2023-05-16 06:36:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06976331789102PUREHEAL Overlapped Compression TherapyJoicom CorporationPH-F012023-05-08
00812120004000Game Ready GRPRO 2.1 Power Supply Class II - RentalAvanos Medical, Inc.303640-RN2023-04-18
00812120001405Game Ready Straight Knee Heat Exchanger, RentalAvanos Medical, Inc.520100-03-RN2023-04-05
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.520160-03-RN2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.520422-03-RN2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.520424-03-RN2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.590100-03-DM2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.590160-03-DM2023-04-05
00812120001559Game Ready Straight Elbow Wrap - DemoAvanos Medical, Inc.590200-03-DM2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.590330-03-DM2023-04-05
00812120001573Game Ready Ankle Wrap - Extra Large - DemoAvanos Medical, Inc.590340-03-DM2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.590422-03-DM2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.590424-03-DM2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.590432-03-DM2023-04-05
00812120001610Game Ready Shoulder Wrap - Large -Left- DemoAvanos Medical, Inc.590434-03-DM2023-04-05
00812120001627Game Ready Back Wrap - DemoAvanos Medical, Inc.590500-03-DM2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.590502-03-DM2023-04-05
00812120001641Game Ready Hip/Groin Wrap - Right - DemoAvanos Medical, Inc.590602-03-DM2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.590604-03-DM2023-04-05
00812120001665Game Ready Hand/Wrist Wrap - DemoAvanos Medical, Inc.590811-03-DM2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.590903-03-DM2023-04-05
00812120001689Game Ready Half Leg Boot Wrap - DemoAvanos Medical, Inc.590906-03-DM2023-04-05
00812120002242Game Ready Connector HoseAvanos Medical, Inc.570302-DM2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.5732402023-04-05
00812120002938Game Ready Med4 Elite Power CordAvanos Medical, Inc.3038772023-04-05
00812120003164Game Ready Full Leg Boot Wrap - Large - DemoAvanos Medical, Inc.590922-03-DM2023-04-05
00812120003171Game Ready Full Leg Boot Wrap - Medium - DemoAvanos Medical, Inc.590923-03-DM2023-04-05
00812120003560Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-AR032023-04-05
00812120003591Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN012023-04-05
00812120003614Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN032023-04-05
00812120003621Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN052023-04-05
00812120003638Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN062023-04-05
00812120003645Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN072023-04-05
00812120003652Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN092023-04-05
00812120003669Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN102023-04-05
00812120003676Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN112023-04-05
00812120003683Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN132023-04-05
00812120003690Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EN142023-04-05
00812120003706Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EX012023-04-05
00812120003737Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-EX082023-04-05
00812120003744Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-FR012023-04-05
00812120003768Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-FR062023-04-05
00812120003799Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-JA122023-04-05
00812120003805Game Ready Med4 Accessory KitAvanos Medical, Inc.303945-PB072023-04-05
00812120003829Game Ready Ankle Heat Exchanger - Large- RentalAvanos Medical, Inc.520330-03-RN2023-04-05
00812120003836Game Ready Back Heat Exchanger - RentalAvanos Medical, Inc.520500-03-RN2023-04-05
00812120003843Game Ready Straght Elbow Wrap - RentalAvanos Medical, Inc.590200-03-RN2023-04-05
00812120003850Game Ready Ankle Wrap - Extra Large - RentalAvanos Medical, Inc.590330-03-RN2023-04-05
00812120003867Game Ready Ankle Wrap - Extra Large - RentalAvanos Medical, Inc.590340-03-RN2023-04-05
00812120003874Game Ready Back Wrap - RentalAvanos Medical, Inc.590500-03-RN2023-04-05
00812120003881Game Ready C-T Spine Wrap - Large - RentalAvanos Medical, Inc.590502-03-RN2023-04-05
00812120003898Game Ready Hip/Groin Wrap - Right - RentalAvanos Medical, Inc.590602-03-RN2023-04-05
00812120003904Game Ready Hip/Groin Wrap - Left- RentalAvanos Medical, Inc.590604-03-RN2023-04-05
00812120003911Game Ready Hand/Wrist Wrap - RentalAvanos Medical, Inc.590811-03-RN2023-04-05
00812120003928Game Ready Flexed Elbow Wrap - RentalAvanos Medical, Inc.590903-03-RN2023-04-05
00812120003935Game Ready Hal Leg Boot Wrap - RentalAvanos Medical, Inc.590906-03-RN2023-04-05
00812120003942Game Ready Full Leg Boot Wrap - Large - RentalAvanos Medical, Inc.590922-03-RN2023-04-05
00812120003959Game Ready Full Leg Boot Wrap - Medium - RentalAvanos Medical, Inc.590923-03-RN2023-04-05
00812120003980Game Ready Connector HoseAvanos Medical, Inc.570300-RN2023-04-05
00812120003997Game Ready US Power Cord 2-Pole RentalAvanos Medical, Inc.303659-RN2023-04-05
00812120004017Game Ready US Power Cored 2-Pole - DemoAvanos Medical, Inc.303659-DM2023-04-05
00812120004031Game Ready Med4 Elite Therapy Hose Assembly - Patient 1Avanos Medical, Inc.5036472023-04-05
00812120004048Game Ready Med4 Elite Therapy Hose Assembly - Patient 2Avanos Medical, Inc.5036482023-04-05
00850033615036ArTek Sport WrapTHERMOTEK, INC.0V9BSPRTUNVWRP012023-03-01
00850033615050ARTEK PRO-01 WRAPTHERMOTEK, INC.0P9BATPUNVWRC012023-03-01
00812120001450Game ReadyAvanos Medical, Inc.590160-03-RN2021-04-07
00812120001467Game ReadyAvanos Medical, Inc.590422-03-RN2021-04-07
00812120001474Game ReadyAvanos Medical, Inc.590424-03-RN2021-04-07
00812120001481Game ReadyAvanos Medical, Inc.590432-03-RN2021-04-07
00812120001498Game ReadyAvanos Medical, Inc.590434-03-RN2021-04-07
00812120002167Game ReadyAvanos Medical, Inc.610200-032021-04-07
00812120003133Game ReadyAvanos Medical, Inc.590922-032021-04-07
00812120001443WRAP, STRAIGHT KNEEAvanos Medical, Inc.590100-03-RN2021-04-02
00812120002198Game ReadyAvanos Medical, Inc.3038012019-12-27
00812120000002Game ReadyAvanos Medical, Inc.520100-032016-08-09
00812120000019Game ReadyAvanos Medical, Inc.520200-032016-08-12
00812120000125Game ReadyAvanos Medical, Inc.5101002016-08-12
00812120000132Game ReadyAvanos Medical, Inc.5101602016-08-12
00812120000149Game ReadyAvanos Medical, Inc.5102002016-08-12
00812120000156Game ReadyAvanos Medical, Inc.5103302016-08-12