FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K Number: K884651
·
Decision Nov 6, 1989
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
34
Review Days
364
Basic Information
- Device Name
- ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
- K Number
- K884651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- BIOMEDICAL LIFE SYSTEMS, INC.
- Date Received
- November 7, 1988
- Decision Date
- November 6, 1989
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by BIOMEDICAL LIFE SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K102051 | PAIN BUDDY | Jul 29, 2011 | Substantially Equivalent |
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| 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 |