FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPEX
DI: 00190446262183
·
Model: 506011TENS
·
DJO, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMPEX
- Primary DI
- 00190446262183
- Version / Model
- 506011TENS
- Company Name
- DJO, LLC
- Labeler DUNS
- 081840873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-02
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- ef014c16-adbe-425b-9a74-ed32b8d68083
Device Description
SET COMPEX PERFORMANCE US 2.0
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
| NYN | Stimulator, electrical, transcutaneous, for arthritis | Neurology | 882.5890 | 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 | 00190446262183 | GS1 |