FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
K Number: K922550
·
Decision Dec 10, 1992
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
12
Review Days
195
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Basic Information
- Device Name
- ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)
- K Number
- K922550
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Verimed Holdings, Inc.
- Date Received
- May 29, 1992
- Decision Date
- December 10, 1992
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Verimed Holdings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981277 | PERIFORM | Nov 20, 1998 | Substantially Equivalent |
| K954127 | BIOFEEDBACK DEVICE | Nov 14, 1995 | Substantially Equivalent |
| K951969 | MYOEXORCISER II FUAL | Jun 14, 1995 | Substantially Equivalent |
| K930670 | PHYACTION 787 | Jul 2, 1993 | 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 |