FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K Number: K061476
·
Decision Jul 26, 2006
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
35
Review Days
57
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Basic Information
- Device Name
- ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
- K Number
- K061476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomedical Life Systems, Inc.
- Date Received
- May 30, 2006
- Decision Date
- July 26, 2006
- 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 Biomedical Life Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172971 | BMLS16-1 | Jul 8, 2018 | Substantially Equivalent |
| K102051 | PAIN BUDDY | Jul 29, 2011 | Substantially Equivalent |
| K042711 | MODEL BMLS03-7 | Mar 14, 2005 | Substantially Equivalent |
| K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 | Nov 23, 2004 | Substantially Equivalent |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | Jul 7, 2004 | Substantially Equivalent |
| K033174 | BMLS03-3 | Jun 30, 2004 | Substantially Equivalent |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | Apr 29, 2004 | Substantially Equivalent |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | Mar 23, 2004 | Substantially Equivalent |
| K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 | Jan 15, 2004 | Substantially Equivalent |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | Aug 19, 2003 | Substantially Equivalent |