FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOPULS 591
K Number: K922036
·
Decision Jun 29, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
44
Review Days
424
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Basic Information
- Device Name
- SONOPULS 591
- K Number
- K922036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Henley Intl.
- Date Received
- May 1, 1992
- Decision Date
- June 29, 1993
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Henley Intl.
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|---|---|---|---|
| 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 |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | Feb 4, 1994 | Substantially Equivalent |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | Jul 21, 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 |