FDA.reportPublic FDA data

Circulating-fluid localized thermal/compression therapy system wrap

Definition
A non-sterile component of a circulating-fluid localized 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
71
Last updated
2026-08-12 10:12:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.1200085632026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.1200085492026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.1200085502026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.1200085512026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.1200085522026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.1200085532026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.1200085542026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.1200085552026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.1200085562026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.1200085572026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.1200085582026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.1200085592026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.1200085602026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.1200085612026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.1200085622026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.1200092902026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.1200092912026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.1200092922026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.1200092932026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.1200092942026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.1200092952026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.1200092962026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.1200092972026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.1200092982026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.1200092992026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.1200093002026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.1200093012026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.1200093022026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.1200093032026-07-31
00812120005397Game Ready* Flexed Elbow SleeveAvanos Medical, Inc.1200093042026-07-31
00812120005403Game Ready* Half Leg Boot SleeveAvanos Medical, Inc.1200093052026-07-31
00812120005410Game Ready* Full Leg Boot Sleeve, LargeAvanos Medical, Inc.1200093062026-07-31
00812120005427Game Ready* Full Leg Boot Sleeve, MediumAvanos Medical, Inc.1200093072026-07-31
00812120005434Game Ready* Straight Knee Heat ExchangerAvanos Medical, Inc.1200093082026-07-31
00812120005441Game Ready* Articulated Knee Heat ExchangerAvanos Medical, Inc.1200093092026-07-31
00812120005458Game Ready* Straight Elbow Heat ExchangerAvanos Medical, Inc.1200093102026-07-31
00812120005465Game Ready* Ankle Heat Exchanger, LargeAvanos Medical, Inc.1200093112026-07-31
00812120005472Game Ready* Ankle Heat Exchanger, Extra LargeAvanos Medical, Inc.1200093122026-07-31
00812120005489Game Ready* Shoulder Heat Exchanger, RightAvanos Medical, Inc.1200093132026-07-31
00812120005496Game Ready* Shoulder Heat Exchanger, LeftAvanos Medical, Inc.1200093142026-07-31
00812120005502Game Ready* Back Heat ExchangerAvanos Medical, Inc.1200093152026-07-31
00812120005519Game Ready* C-T Spine Heat Exchanger, LargeAvanos Medical, Inc.1200093162026-07-31
00812120005526Game Ready* Hip-Groin Heat Exchanger, RightAvanos Medical, Inc.1200093172026-07-31
00812120005533Game Ready* Hip-Groin Heat Exchanger, LeftAvanos Medical, Inc.1200093182026-07-31
00812120005540Game Ready* Hand-Wrist Heat ExchangerAvanos Medical, Inc.1200093192026-07-31
00812120005557Game Ready* Flexed Elbow Heat ExchangerAvanos Medical, Inc.1200093302026-07-31
00812120005564Game Ready* Half Leg Boot Heat ExchangerAvanos Medical, Inc.1200093312026-07-31
00812120005571Game Ready* Full Leg Boot Heat Exchanger, LargeAvanos Medical, Inc.1200093322026-07-31
00812120005588Game Ready* Full Leg Boot Heat Exchanger, MediumAvanos Medical, Inc.1200093332026-07-31
00812120006943Game Ready* 6’ Connector Hose, OTCAvanos Medical, Inc.1200093802026-07-31
00812120006974Game Ready* Articulated Knee WrapAvanos Medical, Inc.1200085472026-07-31
00812120006981Game Ready* Straight Elbow WrapAvanos Medical, Inc.1200085482026-07-31
00812120006998Game Ready* Straight Knee WrapAvanos Medical, Inc.1200085462026-07-31
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-A2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-B12026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-E12026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-E22026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-B22026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-C2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-G2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-T2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.A02-C-032-F2026-07-21
00812120005106Game Ready* Wrap Extender Strap Kit, RentalAvanos Medical, Inc.1200049982026-04-17
00850009827340Aquilo SportsAquilo Sports L.L.C.Full Leg Sleeve (M) - Right2025-08-18
00850009827357Aquilo SportsAquilo Sports L.L.C.Full Leg Sleeve (M) - Left2025-08-18
00850009827388Aquilo SportsAquilo Sports L.L.C.Full Leg Sleeve (L) - Left2025-08-18
00850009827395Aquilo SportsAquilo Sports L.L.C.Full Leg Sleeve (L) - Right2025-08-18
00850009827425Aquilo SportsAquilo Sports L.L.C.Knee Wrap - Left2025-08-18
00850009827432Aquilo SportsAquilo Sports L.L.C.Ankle Wrap - Left2025-08-18
00850009827456Aquilo SportsAquilo Sports L.L.C.Ankle Wrap - Right2025-08-18
00850009827463Aquilo SportsAquilo Sports L.L.C.Knee Wrap - Right2025-08-18