Atlas FDA

KNEE WALKER

FDA 510(k) clearance K833870 · decided 1983-11-29

Clearance details

K-number
K833870
Device name
KNEE WALKER
Applicant
Maddak, Inc.
Decision
Substantially Equivalent
Date received
1983-11-08
Decision date
1983-11-29
Days to decision
21 days
Clearance type
Traditional
Product code
ION
Device class
1
Regulation number
890.5370
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ABLE-X (K120783)Im-Able, Ltd.2012-06-20
STANDEX (K885343)Alt, Inc.1989-05-01
GRAVITY KING (DEEMED SE 87/09/18) (K851065)Unique Functional Products1985-06-13
MOBILIZER (K840551)Lossing Orthopedic, Inc.1984-03-23
FITNESS (K833249)Fitness Equipment Co., Inc.1983-11-07
PEDAL EXERCISER (K832968)Maddak, Inc.1983-09-29
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (K831543)Fred Sammons, Inc.1983-06-24
DELUXE ADJUST-ANGLE BOARD-BK4066 (K831538)Fred Sammons, Inc.1983-06-08
GIREX (K831033)Lancer Assoc.1983-04-27
MADDATRAINER HAND EXERCISER (K830400)Maddak, Inc.1983-03-09
EXERCISER, PASSIVE, NON MEASURING (K830560)Kaye Products, Inc.1983-03-09
BACK ON TRACK INVERSION THERAPY & EXER (K823236)Lossing Orthopedic, Inc.1983-01-21

Recalls involving this device

No recalls on record reference this clearance.