NUGABEST N51-DM-11-2-022-01A-2

GUDID 08800091150132

Personal heating therapeutic device

Nuga Medical Co.,Ltd.

Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager Bed/chair electric massager

• Primary Device ID: 08800091150132
• NIH Device Record Key: ed67a139-5a86-4491-b465-26bf5c82b64b
• Commercial Distribution Discontinuation: 2025-09-07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUGABEST
• Version Model Number: N5-1
• Catalog Number: N51-DM-11-2-022-01A-2
• Company DUNS: 690034673
• Company Name: Nuga Medical Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Device Dimensions

• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram
• Weight: 60 Kilogram

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800091150132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153054

FDA Product Code

• JFB: Table, Physical Therapy, Multi Function

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [NUGABEST]

• 08800091150132: Personal heating therapeutic device
• 08800091121026: Personal heating therapeutic device