FDA UDI
In Commercial Distribution
🇺🇸 United States
Counter
DI: 06970368250017
·
Model: PTS-IV
·
Counter Scientific Development (GZ) Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Counter
- Primary DI
- 06970368250017
- Version / Model
- PTS-IV
- Company Name
- Counter Scientific Development (GZ) Limited
- Labeler DUNS
- 529449417
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 3
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 9ec935fb-7dd5-4a12-a428-32149d5ea31e
Device Description
Pain Therapy Device is a new generation of effective health-care device developed based on physics, bionics, electrobiology and modern microelectronics as well as a lot of clinical practice. The device is used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities(arm), and lower extremities(leg) due to strain from exercise or normal household work activities.
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
- No
- 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 |
|---|---|---|---|---|
| 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 | 06970368250017 | GS1 | ||||
| Package | 26970368250011 | GS1 | 12 | In Commercial Distribution | ||
| Package | 36970368250018 | GS1 | 16 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161537 | 000 |