Atlas FDA

SHOWER CHAIRS

FDA 510(k) clearance K922045 · decided 1992-05-26

Clearance details

K-number
K922045
Device name
SHOWER CHAIRS
Applicant
Medical Device Inspection Co., Inc.
Decision
Substantially Equivalent
Date received
1992-05-01
Decision date
1992-05-26
Days to decision
25 days
Clearance type
Traditional
Product code
INM
Device class
1
Regulation number
890.3100
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Great Neck, NY, 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
NISSIN PEDIATRIC SERIES WHEELCHAIR (K063521)Nissin Medical, Inc.2007-02-05
STRYKER 5050 STRECHAIR (K941738)Stryker Medical1994-05-06
CAREMOR CLINER (K941569)Winco, Inc.1994-04-26
RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (K933000)Winco, Inc.1993-09-30
BENCHES (K926028)Theradapt Products, Inc.1993-03-24
CHAIRS (K926025)Theradapt Products, Inc.1993-03-22
ELD-ARONDAK CHAIR (K926054)Al'S Woodcraft, Inc.1993-03-22
ELD-ARONDAK CHAIR (K926053)Alert Care, Inc.1993-03-22
KAYE SCOOT-ABOUT, MODEL SB1 (K924848)Kaye Products, Inc.1993-02-12
STONEHEART ROLLER AID (K925247)Stoneheart, Inc.1993-02-12
DOLOMITE ROLLATOR (K921917)Seamark Technologies1992-05-26
AMBULATOR (K921752)The Anthros Medical Group1992-05-04

Recalls involving this device

No recalls on record reference this clearance.