FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
K Number: K881211
·
Decision May 11, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
2
Review Days
51
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Basic Information
- Device Name
- TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
- K Number
- K881211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Tru-Trac Therapy Products, Inc.
- Date Received
- March 21, 1988
- Decision Date
- May 11, 1988
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Tru-Trac Therapy Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871633 | TRU-SOUND ULTRASOUND THERAPY UNIT | May 28, 1987 | Substantially Equivalent |