FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOFEEDBACK DEVICE
K Number: K954127
·
Decision Nov 14, 1995
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
12
Review Days
75
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Basic Information
- Device Name
- BIOFEEDBACK DEVICE
- K Number
- K954127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Verimed Holdings, Inc.
- Date Received
- August 31, 1995
- Decision Date
- November 14, 1995
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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Other Clearances by Verimed Holdings, Inc.
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|---|---|---|---|
| K981277 | PERIFORM | Nov 20, 1998 | Substantially Equivalent |
| K951969 | MYOEXORCISER II FUAL | Jun 14, 1995 | Substantially Equivalent |
| K930670 | PHYACTION 787 | Jul 2, 1993 | Substantially Equivalent |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | Dec 10, 1992 | Substantially Equivalent |
| K913912 | VERIMED PERINEOMETER | Jun 16, 1992 | Substantially Equivalent |
| K893220 | VERIMED MYOEXORCISER VERISTIM | Mar 7, 1990 | Substantially Equivalent |
| K892649 | VERIMED MYOEXORCISER III (MYO III) | Dec 13, 1989 | Substantially Equivalent |
| K874212 | VERIMED MYO/PREMS | Aug 8, 1988 | Substantially Equivalent |
| K854193 | ELECTRO-MYOGRAPHIC PERINEOMETER | Jun 9, 1986 | Substantially Equivalent |
| K852963 | MYO-ACTUATOR | Jan 21, 1986 | Substantially Equivalent |