FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID
K Number: K875317
·
Decision Sep 8, 1989
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
8
Review Days
619
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Basic Information
- Device Name
- ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID
- K Number
- K875317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Electro Therapeutic Devices, Inc.
- Date Received
- December 29, 1987
- Decision Date
- September 8, 1989
- 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 Electro Therapeutic Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981272 | ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES | Aug 24, 1998 | Substantially Equivalent |
| K863568 | 'MYOSTIM EX' | Oct 24, 1986 | Substantially Equivalent |
| K863567 | 'TENSAID' | Oct 24, 1986 | Substantially Equivalent |
| K853718 | TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 | Dec 4, 1985 | Substantially Equivalent |
| K853719 | TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 | Dec 4, 1985 | Substantially Equivalent |
| K843119 | ETI TENS BELT | Aug 17, 1984 | Substantially Equivalent |
| K770686 | THERATHERM | Jul 14, 1977 | Substantially Equivalent |