FDA UDI
In Commercial Distribution
🇺🇸 United States
NUGABEST
DI: 08800091150132
·
Model: N5-1
·
Nuga Medical Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NUGABEST
- Primary DI
- 08800091150132
- Version / Model
- N5-1
- Catalog Number
- N51-DM-11-2-022-01A-2
- Company Name
- Nuga Medical Co.,Ltd.
- Labeler DUNS
- 690034673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 3
- Public Version Date
- 2025-12-04
- Public Version Status
- Update
- Public Device Record Key
- ed67a139-5a86-4491-b465-26bf5c82b64b
- Distribution End Date
- 2029-11-30
Device Description
Personal heating therapeutic device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | Physical Medicine | 890.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34488 | Bed/chair electric massager | A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800091150132 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153054 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 60 | Kilogram |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit