FDA UDI
In Commercial Distribution
🇺🇸 United States
Electronic Stimulator
DI: 06974700021112
·
Model: uLumb-9533A
·
Shenzhen Leqing Medical Instrument Co., LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Electronic Stimulator
- Primary DI
- 06974700021112
- Version / Model
- uLumb-9533A
- Company Name
- Shenzhen Leqing Medical Instrument Co., LTD
- Labeler DUNS
- 710753231
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-17
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 4db3c403-1d32-4e2b-b64d-ebc88f86d52b
Device Description
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974700021112 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223428 | 000 |