FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TMR48
K Number: K953342
·
Decision Sep 8, 1995
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
19
Review Days
59
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Basic Information
- Device Name
- TMR48
- K Number
- K953342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pride Health Care, Inc.
- Date Received
- July 11, 1995
- Decision Date
- September 8, 1995
- Product Code
- INO
- 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 |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
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|---|---|---|---|
| K945936 | JAZZY | May 28, 1996 | Substantially Equivalent |
| K944940 | EURO SC500 | Feb 12, 1996 | Substantially Equivalent |
| K944277 | DYNAMO | Dec 28, 1994 | Substantially Equivalent for Some Indications |
| K944939 | CELEBRITY XL SC445 | Nov 7, 1994 | Substantially Equivalent |
| K931231 | SIDEKICK II | May 5, 1994 | Substantially Equivalent for Some Indications |
| K926295 | LEGEND SC 300 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K930953 | CELEBRITY SC440 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K930952 | PRIDE LEGEND SC-340 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K926296 | CELEBRITY SC400 | Mar 28, 1994 | Substantially Equivalent for Some Indications |
| K926499 | SHUTTLE SC-140 | Mar 28, 1994 | Substantially Equivalent |