FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioWaveGO RX
K Number: K210202
·
Decision Feb 24, 2021
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- BioWaveGO RX
- K Number
- K210202
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biowave Corporation
- Date Received
- January 25, 2021
- Decision Date
- February 24, 2021
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Biowave Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K261522 | BioWave BioWraps | Jun 3, 2026 | Substantially Equivalent |
| K203158 | BioWave BioWraps | Jul 8, 2021 | Substantially Equivalent |
| K180943 | BioWaveGO | Aug 17, 2018 | Substantially Equivalent |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Sep 25, 2015 | Substantially Equivalent |
| K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | Feb 1, 2008 | Substantially Equivalent |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Aug 15, 2006 | Substantially Equivalent |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Dec 13, 2005 | Substantially Equivalent |