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510(k) K950701

WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER by Wahl Clipper Corp. — Product Code IMA

K950701 is an FDA 510(k) premarket notification submitted by Wahl Clipper Corp. for the device "WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER". The FDA issued a decision of Substantially Equivalent on March 24, 1995. The device falls under product code IMA (Pack, Heat, Moist), a Class I device regulated under 21 CFR 890.5730. Wahl Clipper Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
February 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Heat, Moist
Device Class
Class I
Regulation Number
890.5730
Review Panel
PM
Submission Type

Other clearances by Wahl Clipper Corp.

  • K944909 — WAHL FRESH FACE (May 8, 1995)
  • K946162 — 3M(TM) SURGICAL SLIPPER, 9660 SERIES (January 24, 1995)
  • K944024 — STIMU-TAP (December 8, 1994)
  • K940683 — WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA (June 9, 1994)
  • K941594 — WAHL DOUBLE COMFORT MASSAGER (June 9, 1994)
  • K941412 — WAHL COMPACT COMFORT MASSAGER (June 9, 1994)
  • K940837 — WAHL(R) FOOT COMFORT MASSAGER (June 9, 1994)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K841698 — HEAT PACK (May 10, 1984)
  • K832803 — STEAM PAK MOIST HEAT (September 20, 1983)
  • K823622 — INSULATED THERMOELASTOMER MITT (December 30, 1982)
  • K803177 — MOIST HEAT PACK (December 31, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)
  • K790904 — STAO-HOTPACK (May 18, 1979)

FDA data resources