FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TELESONIC BODY STIMULATOR
K Number: K872606
·
Decision Dec 22, 1987
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
12
Review Days
173
Basic Information
- Device Name
- TELESONIC BODY STIMULATOR
- K Number
- K872606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- TELESONIC, INC.
- Date Received
- July 2, 1987
- Decision Date
- December 22, 1987
- Product Code
- IPF
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by TELESONIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | Jan 19, 1982 | Substantially Equivalent |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | Jan 19, 1982 | Substantially Equivalent |
| K813344 | POST-AURICULAR HEARING AID MODEL ASP-103 | Dec 31, 1981 | Substantially Equivalent |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | Dec 31, 1981 | Substantially Equivalent |
| K811031 | TELESONIC & ARCON | Jul 1, 1981 | Substantially Equivalent |
| K802596 | TELESONIC, ARCON & SOUNDEX ASP 102 | Nov 12, 1980 | Substantially Equivalent |
| K802597 | TELESONIC ARCON & SOUNDEX ASP 101 | Nov 12, 1980 | Substantially Equivalent |
| K801067 | TELESONIC, GENERIC & SOUNDEX C-102 | May 28, 1980 | Substantially Equivalent |
| K801066 | TELESONIC, SOUNDEX & GENERIC V-101 | May 28, 1980 | Substantially Equivalent |
| K800105 | TELESONIC (HEARING AID) | Feb 11, 1980 | Substantially Equivalent |