Model: P-1
DI: 08436587171062
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2edb18f8-e782-483a-8434-b7fea9ad196d
Distribution Status:
In Commercial Distribution
DUNS Number:
468878594
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08436587171062
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47363
Name: Physical therapy insulation patch
Definition:
A non-sterile device (a patch) intended to be applied externally to a body area to provide heat insulation to an inflamed joint, providing an analgesic effect alleviating localized pain in the joint. It is typically layered (e.g., an inner layer to retain heat and an outer layer to repel cold) and has an adhesive surface for adherence to the body surface. It is used for the treatment of local rheumatic conditions (e.g., joint and muscular pains, sports traumas, stiff neck, lumbago). It is typically available [non-prescription] over-the-counter (OTC). This is a single-use device.
FDA Product Codes
IMD
Pack, Hot Or Cold, Disposable