Identity
- Trade Name
- BioWave BLUE Back BioWrap S/M FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- BioWrap Wearable Compression Electrode Garment that utilizes BioWave Velcro-backed noninvasive electrodes that work exclusively with BioWave High Frequency Neurostimulators. FDA UDI
- Model / Reference
- BWRPBLUE-BACK-SM FDA UDI
- Description
- BioWrap Wearable Compression Electrode Garment that utilizes BioWave Velcro-backed noninvasive electrodes that work exclusively with BioWave High Frequency Neurostimulators. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859911006584 FDA UDI
- 510(k) Number
- K203158 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, reusable
BioWave BLUE Back BioWrap S/M by BioWave Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203158 also covers:
- BioWave BLUE Back BioWrap L/XL — BioWave Corporation
- BioWave BLUE Knee BioWrap L/XL — BioWave Corporation
- BioWave BLUE Knee BioWrap S/M — BioWave Corporation
- BioWave Noninvasive Velcro Backed Electrodes - B-Set — BioWave Corporation
- BioWave Silver Back BioWrap L/XL — BioWave Corporation
- BioWave Silver Back BioWrap S/M — BioWave Corporation
- BioWave Silver Foot-Ankle BioWrap L/XL — BioWave Corporation
- BioWave Silver Foot-Ankle BioWrap S/M — BioWave Corporation
- BioWave Silver Knee BioWrap L/XL — BioWave Corporation
- BioWave Silver Knee BioWrap S/M — BioWave Corporation
- BioWave Silver Thigh-Calf BioWrap L/XL — BioWave Corporation
- BioWave Silver Thigh-Calf BioWrap S/M — BioWave Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- BioWave Corporation
Sources (1)
- FDA UDI d4ca121a-5a6f-4f65-a206-bc5678356a3d 34 fields · synced Jun 9, 2026