FDA UDI
In Commercial Distribution
🇺🇸 United States
Golden State Medical HD Combo
DI: 00860001588309
·
Model: ECS322P
·
International Trade Group Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Golden State Medical HD Combo
- Primary DI
- 00860001588309
- Version / Model
- ECS322P
- Company Name
- International Trade Group Inc
- Labeler DUNS
- 079427100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-12
- Public Version
- 1
- Public Version Date
- 2023-10-20
- Public Version Status
- New
- Public Device Record Key
- e4517bb2-a6ec-4ac4-bb2d-e0e27adedd4b
Device Description
GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. GSM HD Combo Neuromuscular electrical stimulation (NMES): The device is intended to stimulate muscles in order to facilitate and improve muscle performance.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 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 | 00860001588309 | GS1 |
Customer Contacts
- Phone
- 6146572881
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 128 | Millimeter | |
| Width | 67 | Millimeter | |
| Depth | 25 | Millimeter | |
| Weight | 0.12 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius