FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BTE WS30
K Number: K933611
·
Decision Jun 20, 1994
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
7
Review Days
336
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE BTE WS30
- K Number
- K933611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Baltimore Therapeutic Equipment Co.
- Date Received
- July 19, 1993
- Decision Date
- June 20, 1994
- Product Code
- ISD
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ISD), ordered by most recent decision date.
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
FDA 510(k)
FDA Class 2
·Physical Medicine
REAL Immersive System
FDA 510(k)
FDA Class 2
·Physical Medicine
ActiSpec Activity Monitor
FDA 510(k)
FDA Class 2
·Physical Medicine
ERGOSELECT/GE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTITRAINER
FDA 510(k)
FDA Class 2
·Physical Medicine
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Baltimore Therapeutic Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K955106 | BTE CPM-20 | Dec 29, 1995 | Substantially Equivalent |
| K955105 | BTE CPM-10 | Dec 29, 1995 | Substantially Equivalent |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Jun 27, 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 |