FDA UDI
In Commercial Distribution
🇺🇸 United States
FlowKeepers
DI: 00860012717637
·
Model: EP-201 Pro Bundle
·
KRENERB
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FlowKeepers
- Primary DI
- 00860012717637
- Version / Model
- EP-201 Pro Bundle
- Company Name
- KRENERB
- Labeler DUNS
- 144867619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-14
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- ea458896-4d95-412b-9cb9-3a47a951df25
Device Description
FlowKeepers Pro Bundle with two devices and 8 gel pads.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
| 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 |
|---|---|---|---|---|
| 65319 | Electrode conductive skin pad, reusable | A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., transcutaneous electrical stimulation electrode) and the skin surface. It is typically in the form of a gel pad/patch designed to adhere the electrode (not included) to the skin surface. This is a reusable device. | No | Active |
| 67593 | Muscle performance enhancement electromagnetic stimulator | An electrically-powered device designed to apply an electromagnetic (EM) field to a limb to stimulate healthy muscles, to improve muscle performance and prevent muscle atrophy. It consists of an apparatus with an open chamber into which a patient’s limb is inserted, whereby pulsed stimulation is delivered without causing muscle contraction, stress or strain; it is not designed for deep-tissue stimulation to treat musculoskeletal disorders or body pain. It is intended for use exclusively in a professional setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012717637 | GS1 |
Customer Contacts
- Phone
- 3023885016
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity