FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
WELL-LIFE OTC EMS SYSTEM
K Number: K102786
·
Decision Jul 1, 2011
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
152
Applicant Total
16
Review Days
277
Basic Information
- Device Name
- WELL-LIFE OTC EMS SYSTEM
- K Number
- K102786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WELL-LIFE HEALTHCARE LIMITED
- Date Received
- September 27, 2010
- Decision Date
- July 1, 2011
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by WELL-LIFE HEALTHCARE LIMITED
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K123075 | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E | Jul 11, 2013 | Substantially Equivalent |
| K121353 | MINI PATCH | Sep 7, 2012 | Substantially Equivalent |
| K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A | Jun 25, 2010 | Substantially Equivalent |
| K091757 | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 | Feb 5, 2010 | Substantially Equivalent |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | Oct 8, 2009 | Substantially Equivalent |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP | Apr 10, 2009 | Substantially Equivalent |