Home / 510(k) Clearances / K841700

510(k) K841700

WALK & ROLL by Maddak, Inc. — Product Code INM

K841700 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "WALK & ROLL". The FDA issued a decision of Substantially Equivalent on May 11, 1984. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Maddak, Inc.

  • K841698 — HEAT PACK (May 10, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)
  • K833090 — SENSORY ROLLER MASSAGER (October 14, 1983)

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)

FDA data resources