FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BATTLE CREEK PILLOW
K Number: K882264
·
Decision Aug 9, 1988
Classifications
1
FEI Numbers
297
Registration Numbers
297
Same Product Code
26
Applicant Total
7
Review Days
70
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Basic Information
- Device Name
- BATTLE CREEK PILLOW
- K Number
- K882264
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Battle Creek Equipment Co.
- Date Received
- May 31, 1988
- Decision Date
- August 9, 1988
- Product Code
- IQK
- 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 |
|---|---|---|---|
| IQK | Orthosis, Cervical | FDA class 1 | Physical Medicine |
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Other Clearances by Battle Creek Equipment Co.
| K Number | Device Name | ||
|---|---|---|---|
| K863884 | PULSESTAR EXERCISE BIKE | Oct 23, 1986 | Substantially Equivalent |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | Dec 27, 1985 | Substantially Equivalent |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | Dec 17, 1985 | Substantially Equivalent |
| K851237 | THERMOPHORE ELECTRIC FOMENTATION UNIT | Jul 29, 1985 | Substantially Equivalent |
| K840280 | ROAD RUNNER ELECTRIC TREADMILL | Feb 4, 1984 | Substantially Equivalent |
| K791866 | STANDARD HEALTH BIKE MODEL 019 | Oct 4, 1979 | Substantially Equivalent |