Home › Device types › IME
Pack, Hot Or Cold, Reusable
FDA product code IME · Class 1 · Physical Medicine
687
Registered devices
323
Adverse events
12
Recalls
27
510(k) clearances
Devices with this code
B-COOL HIP WRAP ONLY — Bird & Cronin, LLCSharper Image — Merchsource, LLCArctic Flex — VIVE HEALTH LLCBingfan — Shanghai BingFan Industrial Co., Ltd.Arctic Flex — VIVE HEALTH LLCWALGREENS — WALGREEN CO.Arctic Flex — VIVE HEALTH LLCSquid Go — PORTABLE THERAPEUTIXB-COOL ARTHROSCOPIC KNEE WRAP 14" — Bird & Cronin, LLCCold Compression Wrap, Pro-Ankle Wrap — Manamed, Inc.Freeze Sleeve — Jiangsu Huanyi Industrial Co. LTDWalgreens — WALGREEN CO.CARDINAL HEALTH — CARDINAL HEALTH 200, LLCSDP — South Dakota Partners Inc.Bingfan — Shanghai BingFan Industrial Co., Ltd.Arctic Flex — VIVE HEALTH LLCMunchkin — MUNCHKIN, INC.Zhanzun — Anhui Zhanzun Industrial Co.,Ltd.Arctic Flex — VIVE HEALTH LLCSkin Cooler Roller - SMALL (blue) — FABINJECT LLCSDP — South Dakota Partners Inc.DeRoyal — DEROYAL INDUSTRIES, INC.VIVE — VIVE HEALTH LLCBed Buddy — COMPASS HEALTH BRANDS CORP.
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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