FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4000 PT EXERCISE SYSTEM
K Number: K912057
·
Decision Oct 24, 1991
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
11
Review Days
168
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Basic Information
- Device Name
- 4000 PT EXERCISE SYSTEM
- K Number
- K912057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tri-Tech, Inc.
- Date Received
- May 9, 1991
- Decision Date
- October 24, 1991
- Product Code
- ISD
- 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 |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
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Other Clearances by Tri-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971111 | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER | Jun 16, 1997 | Substantially Equivalent |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Jun 20, 1995 | Substantially Equivalent |
| K922343 | TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT | Feb 17, 1994 | Unknown |
| K922342 | TRI-TECH INC. CUSTOM BLOOD ALCOHOL | Aug 27, 1993 | Unknown |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | Dec 17, 1991 | Substantially Equivalent |
| K912058 | GAUNTLET STAIR CLIMBER | Oct 24, 1991 | Substantially Equivalent |
| K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER | Oct 24, 1991 | Substantially Equivalent |
| K900983 | TRI-TECH URINE SPECIMEN KIT | Sep 17, 1990 | Substantially Equivalent |
| K843839 | STAT/PB REAGENT | Jan 3, 1985 | Substantially Equivalent |
| K813075 | TRITEC DOC TM | Dec 9, 1981 | Substantially Equivalent |