Home › Device types › IME
Pack, Hot Or Cold, Reusable
FDA product code IME · Class 1 · Physical Medicine
709
Registered devices
391
Adverse events
12
Recalls
27
510(k) clearances
Devices with this code
Arctic Flex — VIVE HEALTH LLC1/2 LUMBAR ROLL STRAP-FIRM DEN — Bird & Cronin, LLCArctic Flex — VIVE HEALTH LLCFreeze Sleeve — Jiangsu Huanyi Industrial Co. LTDCRYOPUSH — Chengdu Cryo-push Medical Technology Co.,Ltd.Oasis REST & RELIEF Eye Mask — OASIS MEDICAL, INC.NuvoMed — NUVOMED, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Freeze Sleeve — Jiangsu Huanyi Industrial Co. LTDZhanzun — Anhui Zhanzun Industrial Co.,Ltd.Dr. Brown's — Dr. Brown's CompanyTrue Comfort Shoulder Compression Wrap — HOME AIDE DIAGNOSTICS, INC.Freeze Sleeve — Jiangsu Huanyi Industrial Co. LTDB-COOL CRYO WRAP KIT W/2 COLD PACKS — Bird & Cronin, LLCSquid — PORTABLE THERAPEUTIXBed Buddy — Drive Devilbiss HealthcareHOMEDICS — FKA DISTRIBUTING CO., LLCPROFIT — PANTYMED S.A.Arctic Flex — VIVE HEALTH LLCMeijer Hot & Cold Wrap Ultra-Forming — MEIJER, INC.B-COOL 1.0 HOT/COLD 5.5"X11" 2EA/PK — Bird & Cronin, LLCTheraBurpee Reusable Hot & Cold Gel Packs - 2pk — MUNCHKIN, INC.DONJOY PERFORMANCE — DJO, LLCHydraHeat — Drive Devilbiss Healthcare
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | DJO, LLC | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Inf |
| 2021-12-15 | MEDLINE INDUSTRIES, LP - Northfield | The product contains natural rubber latex but the label states that it does not. |
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