FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BTE CPM-20
K Number: K955106
·
Decision Dec 29, 1995
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
7
Review Days
51
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Basic Information
- Device Name
- BTE CPM-20
- K Number
- K955106
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baltimore Therapeutic Equipment Co.
- Date Received
- November 8, 1995
- Decision Date
- December 29, 1995
- Product Code
- BXB
- 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
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Other Clearances by Baltimore Therapeutic Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K955105 | BTE CPM-10 | Dec 29, 1995 | Substantially Equivalent |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Jun 27, 1994 | Substantially Equivalent |
| K933611 | THE BTE WS30 | Jun 20, 1994 | Substantially Equivalent |
| K924414 | THE BTE DYNAMIC LIFT | Feb 12, 1993 | Substantially Equivalent |
| K895881 | MOTIONSPECT | Apr 10, 1990 | Substantially Equivalent |
| K800007 | WORK SIMULATOR | Jan 21, 1980 | Substantially Equivalent |