Pack, Heat, Moist

Device Code: 5085

Product Code(s): IMA

Device Classification Information

• Device Type ID: 5085
• Device Name: Pack, Heat, Moist
• Regulation Description: Moist Heat Pack.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 890.5730 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IMA
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5085
• Device: Pack, Heat, Moist
• Product Code: IMA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Moist Heat Pack.
• CFR Regulation Number: 890.5730 [🔎]

Premarket Reviews
Manufacturer	Decision
RACHEL'S REMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 21:00:00