510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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The Standing Company

Saginaw, MI, US

THE STANDING COMPANY appears in FDA device records in Saginaw, MI. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for The Standing Company between 1996 and 2004. The busiest year on record is 1996, with 1. The most recent is 2004, with 1.

Clearances by year, as a table
510(k) clearance decisions for The Standing Company, by decision year
YearClearances
19961
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K032101POWERSTAND STAND-UP WHEELCHAIRIPLSubstantially Equivalent
K962278SUPERSTAND STAND-UP WHELLCHAIRIPLSubstantially Equivalent

Registered establishments

FDA registered establishments for The Standing Company, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30074949043007494904THE STANDING COMPANY5848 Dixie Highway, Saginaw, MI 48601 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0993-2014Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain