FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Focus TENS Therapy, Model PM710-M/-L
K Number: K183215
·
Decision Sep 7, 2019
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
68
Review Days
292
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Focus TENS Therapy, Model PM710-M/-L
- K Number
- K183215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omron Healthcare, Inc.
- Date Received
- November 19, 2018
- Decision Date
- September 7, 2019
- Product Code
- NUH
- 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 |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
FDA 510(k)
FDA Class 2
·Neurology
TENS/EMS device (GUSE01)
FDA 510(k)
FDA Class 2
·Neurology
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
FDA 510(k)
FDA Class 2
·Neurology
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
FDA 510(k)
FDA Class 2
·Neurology
VEINOPLUS Back
FDA 510(k)
FDA Class 2
·Neurology
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Omron Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Oct 8, 2024 | Unknown |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Apr 1, 2021 | Substantially Equivalent |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Apr 17, 2019 | Substantially Equivalent |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Mar 14, 2019 | Substantially Equivalent |
| K182120 | Maxpower Relief | Jan 10, 2019 | Substantially Equivalent |
| K181992 | Heat Pain Pro | Nov 9, 2018 | Substantially Equivalent |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Nov 9, 2018 | Substantially Equivalent |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Nov 8, 2018 | Substantially Equivalent |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Nov 2, 2018 | Substantially Equivalent |
| K172079 | Avail | Oct 19, 2017 | Substantially Equivalent |