FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K Number: K092763
·
Decision Oct 8, 2009
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
22
Review Days
29
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Basic Information
- Device Name
- IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
- K Number
- K092763
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Well-Life Healthcare Limited
- Date Received
- September 9, 2009
- Decision Date
- October 8, 2009
- Product Code
- LIH
- 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | FDA class 2 | Neurology |
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| K213091 | Well-Life TENS/EMS/Heating Stimulator | Feb 19, 2022 | Substantially Equivalent |
| K200942 | Well-Life Garment Electrodes (GM Series) | Jun 1, 2021 | Substantially Equivalent |
| K172809 | OTC Combo TENS/EMS System | Oct 18, 2017 | Substantially Equivalent |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | Jan 17, 2017 | Substantially Equivalent |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | Dec 5, 2016 | Substantially Equivalent |
| K141299 | OTC COMBO TENS/EMS SYSTEM | Nov 14, 2014 | Substantially Equivalent |
| K133723 | OTC PATCH | Jan 28, 2014 | Substantially Equivalent |