HotRock

GUDID 00860000412711

HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.

MEDROCK, INC

External manual massager, clinical

• Primary Device ID: 00860000412711
• NIH Device Record Key: dd89019b-5a0b-440e-b2e0-e6c4d35d02c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HotRock
• Version Model Number: HR-001
• Company DUNS: 034446946
• Company Name: MEDROCK, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000412711 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-08-20
• Device Publish Date: 2020-06-16