FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT
K Number: K861864
·
Decision Jul 14, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
8
Review Days
60
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Basic Information
- Device Name
- MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT
- K Number
- K861864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- I-Rep, Inc.
- Date Received
- May 15, 1986
- Decision Date
- July 14, 1986
- Product Code
- IMJ
- 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 |
|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by I-Rep, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930692 | LATHAM TABLE | Feb 2, 1994 | Substantially Equivalent |
| K930691 | ACCUTRAC TRACTION UNIT | Jul 22, 1993 | Substantially Equivalent |
| K854947 | REHABILITATION TABLES | Jan 3, 1986 | Substantially Equivalent |
| K851690 | ADJUSTABLE TREATMENT TABLES | May 7, 1985 | Substantially Equivalent |
| K842268 | VACUPULSE VACUUM UNIT | Jul 20, 1984 | Substantially Equivalent |
| K832940 | ROTAGYM | Nov 7, 1983 | Substantially Equivalent |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | Oct 15, 1982 | Substantially Equivalent |