FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI TENS
K Number: K821523
·
Decision Jun 16, 1982
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
12
Review Days
26
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Basic Information
- Device Name
- OMNI TENS
- K Number
- K821523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Omni Intl., Inc.
- Date Received
- May 21, 1982
- Decision Date
- June 16, 1982
- 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 Omni Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984066 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM | Jan 13, 1999 | Substantially Equivalent |
| K984064 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE | Jan 8, 1999 | Substantially Equivalent |
| K853255 | OMNIMED I.V. SOLUTION ADMIN. SET | Aug 23, 1985 | Substantially Equivalent |
| K851938 | OMNIMED SURGICAL GOWN | Jun 28, 1985 | Substantially Equivalent |
| K851654 | OMNIMED CLAMP | May 31, 1985 | Substantially Equivalent |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | May 23, 1985 | Substantially Equivalent |
| K850706 | F-SERIES IMPLANT | Apr 10, 1985 | Substantially Equivalent |
| K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET | Feb 22, 1985 | Substantially Equivalent |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | Jan 24, 1985 | Substantially Equivalent |
| K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | Jul 18, 1983 | Substantially Equivalent |