FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMPUTERIZED TESTING AND EXERCISE SYSTEMS
K Number: K926313
·
Decision Feb 4, 1994
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
44
Review Days
416
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Basic Information
- Device Name
- COMPUTERIZED TESTING AND EXERCISE SYSTEMS
- K Number
- K926313
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Henley Intl.
- Date Received
- December 15, 1992
- Decision Date
- February 4, 1994
- 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 Henley Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES | Nov 15, 1995 | Substantially Equivalent |
| K926279 | UPPER BODY EXERCISER | May 5, 1994 | Substantially Equivalent |
| K926278 | STAIR CLIMBER | May 5, 1994 | Substantially Equivalent |
| K926287 | EXERCISE BICYCLE | Mar 22, 1994 | Substantially Equivalent |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Mar 18, 1994 | Substantially Equivalent |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | Jul 21, 1993 | Substantially Equivalent |
| K922036 | SONOPULS 591 | Jun 29, 1993 | Substantially Equivalent |
| K926316 | TRUE-TRAC, STRATUS | Mar 24, 1993 | Substantially Equivalent |
| K920983 | SONOPULS 590 | Mar 9, 1993 | Substantially Equivalent |
| K921828 | TEAM-MC II | Sep 22, 1992 | Substantially Equivalent |