FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SMART TENS, MODEL: D-BC05T
K Number: K091045
·
Decision Dec 18, 2009
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
7
Review Days
249
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Basic Information
- Device Name
- SMART TENS, MODEL: D-BC05T
- K Number
- K091045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Body Clock Health Care, Ltd.
- Date Received
- April 13, 2009
- Decision Date
- December 18, 2009
- 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 Body Clock Health Care, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K041359 | BODY CLOCK STIMPLUS AND STIMPLUS PRO | Aug 20, 2004 | Substantially Equivalent |
| K022849 | BODY CLOCK TENS N' TONE | May 20, 2003 | Substantially Equivalent |
| K021846 | 804SIII; 804W; LIBRA TENS; 410; S-TENS II | Nov 22, 2002 | Substantially Equivalent |
| K022731 | V TENS PLUS | Nov 14, 2002 | Substantially Equivalent |
| K022493 | EMS 400 | Oct 11, 2002 | Substantially Equivalent |
| K022076 | FIRST CHOICE & FIRST CHOICE PLUS | Sep 24, 2002 | Substantially Equivalent |