FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K Number: K981272
·
Decision Aug 24, 1998
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
90
Applicant Total
8
Review Days
139
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Basic Information
- Device Name
- ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
- K Number
- K981272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro Therapeutic Devices, Inc.
- Date Received
- April 7, 1998
- Decision Date
- August 24, 1998
- Product Code
- MQX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | FDA class 2 | General Hospital |
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Other Clearances by Electro Therapeutic Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875317 | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID | Sep 8, 1989 | 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 |