FDA UDI
In Commercial Distribution
🇺🇸 United States
Healthpal
DI: 06974000130026
·
Model: FE-7513
·
Xiamen Healthpal Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Healthpal
- Primary DI
- 06974000130026
- Version / Model
- FE-7513
- Company Name
- Xiamen Healthpal Electronic Co., Ltd.
- Labeler DUNS
- 553874367
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-02
- Public Version
- 1
- Public Version Date
- 2025-01-10
- Public Version Status
- New
- Public Device Record Key
- db68d54d-8b15-4ce1-8c93-241132dd53f9
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60310 | Body infrared reflective phototherapy skin patch | A skin patch intended to reflect naturally emitted infrared energy back into the body, with a reduced range of wavelength (phototherapeutic stimulation of the skin), to assist one or more of the following therapeutic outcomes: wound healing, pain relief, improved energy, improved sleep, reduced cravings, and general wellbeing. It can be applied as a single, double or multiple patch(es). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974000130026 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211850 | 000 |