FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER
K Number: K950701
·
Decision Mar 24, 1995
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
7
Applicant Total
8
Review Days
37
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Basic Information
- Device Name
- WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER
- K Number
- K950701
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5730
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wahl Clipper Corp.
- Date Received
- February 15, 1995
- Decision Date
- March 24, 1995
- Product Code
- IMA
- 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 |
|---|---|---|---|
| IMA | Pack, Heat, Moist | FDA class 1 | Physical Medicine |
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Other Clearances by Wahl Clipper Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K944909 | WAHL FRESH FACE | May 8, 1995 | Substantially Equivalent |
| K946162 | 3M(TM) SURGICAL SLIPPER, 9660 SERIES | Jan 24, 1995 | Substantially Equivalent |
| K944024 | STIMU-TAP | Dec 8, 1994 | Substantially Equivalent |
| K941412 | WAHL COMPACT COMFORT MASSAGER | Jun 9, 1994 | Substantially Equivalent for Some Indications |
| K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA | Jun 9, 1994 | Substantially Equivalent for Some Indications |
| K940837 | WAHL(R) FOOT COMFORT MASSAGER | Jun 9, 1994 | Substantially Equivalent for Some Indications |
| K941594 | WAHL DOUBLE COMFORT MASSAGER | Jun 9, 1994 | Substantially Equivalent for Some Indications |