FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Heat Pain Pro
K Number: K181992
·
Decision Nov 9, 2018
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
68
Review Days
106
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Basic Information
- Device Name
- Heat Pain Pro
- K Number
- K181992
- 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
- July 26, 2018
- Decision Date
- November 9, 2018
- 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 |
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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 |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | Sep 7, 2019 | 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 |
| 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 |