FDA UDI
In Commercial Distribution
🇺🇸 United States
TimeWaver Frequency
DI: 04251784202067
·
Model: REF 0002
·
TimeWaver Production GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TimeWaver Frequency
- Primary DI
- 04251784202067
- Version / Model
- REF 0002
- Catalog Number
- 0002
- Company Name
- TimeWaver Production GmbH
- Labeler DUNS
- 341997962
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-23
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 2170e9de-97b0-457c-9b85-2b66e3e07803
Device Description
TimeWaver Frequency is an electrical stimulation device that supports the treatment of symptoms of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 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 | 04251784202067 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212832 | 000 |