510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Pdg Product Design Group Inc

Richmond British Columbia, CA

PDG PRODUCT DESIGN GROUP, INC. appears in FDA device records in Richmond British Columbia, CA. FDA records list 8 510(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
8
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Pdg Product Design Group Inc between 1996 and 2017. The busiest year on record is 1997, with 2. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pdg Product Design Group Inc, by decision year
YearClearances
19961
19972
19991
20061
20071
20141
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K163432Stellar LEAPIORSubstantially Equivalent
K140023ELEVATIONIORSubstantially Equivalent
K063736FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50IORSubstantially Equivalent
K061475ASTROTILT MANUAL WHEELCHAIRIORSubstantially Equivalent
K990557THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIRIORSubstantially Equivalent
K971389ECLIPSE 400 MANUALLY OPERATED WHEELCAIRIORSubstantially Equivalent
K970311BENTLEY MANUALLY OPERATED WHEELCHAIRIORSubstantially Equivalent
K961743ECLIPSE 600 MANUALLY OPERATED WHEELCHAIRIORSubstantially Equivalent

Registered establishments

FDA registered establishments for Pdg Product Design Group Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96818273003748905PDG PRODUCT DESIGN GROUP, INC.14273 Knox Way, Richmond British Columbia V6V 2Z4 CA2026

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-2695-2014Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 JrThe hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.Class IITerminated

Verification record

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