510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Merits Health Products, Inc.

Fort Myers, FL, US

MERITS HEALTH PRODUCTS, INC. appears in FDA device records in Fort Myers, FL. FDA records list 31 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
3
Registered establishments
4

FDA records under these names

1 name

FDA records resolved to Merits Health Products, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Merits Holdings Co. dba Merits Health Products, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 31 510(k) clearances for Merits Health Products, Inc. between 1993 and 2022. The busiest year on record is 2001, with 8. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Merits Health Products, Inc., by decision year
YearClearances
19931
19941
19961
19981
19991
20001
20018
20021
20053
20064
20082
20102
20121
20131
20152
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220529Merits P335 Powered WheelchairITISubstantially Equivalent
K142912Merits Yoga Power Scooter, S542INISubstantially Equivalent
K142162MERITS TRANSFORMER POWER SCOOTER, S941INISubstantially Equivalent
K122357MERITS MODEL P322FWD POWERED WHEELCHAIRITISubstantially Equivalent
K113577MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIRITISubstantially Equivalent
K092859MERITS MODEL N SERIES NEBULIZER COMPRESSORSCAFSubstantially Equivalent
K091716MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORYCAWSubstantially Equivalent
K073110MERITS E600 SERIES STAIR LIFTILKSubstantially Equivalent
K073513MERITS E700 PORCE LIFTINGSubstantially Equivalent
K053490MERITS HEALTH PRODUCTS PORTABLE NEBULIZERCAFSubstantially Equivalent
K053230MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSCAWSubstantially Equivalent
K053229MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSCAWSubstantially Equivalent
K060212MERITS MODEL E SERIES LIFT CHAIRSINOSubstantially Equivalent
K052650PIONEER U601 SERIES ASPIRATORBTASubstantially Equivalent
K050430MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORCAWSubstantially Equivalent
K041823PIONEER U121 SERIES CPAPBZDSubstantially Equivalent
K014301MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSCAWSubstantially Equivalent
K013788TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5INISubstantially Equivalent
K012802MP3CF ELECTRIC WHEELCHAIRITISubstantially Equivalent
K011844MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSCAWSubstantially Equivalent
K011513MP3U, POWER WHEELCHAIRITISubstantially Equivalent
K011751TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3INISubstantially Equivalent
K011753TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4INISubstantially Equivalent
K011687MP-3C POWER BASE CHAIR, MODEL MP3CITISubstantially Equivalent
K010380MP3HD BIG BOY, POWER WHEELCHAIRITISubstantially Equivalent
K003815TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEERINISubstantially Equivalent
K993032MODIFICATION TO MP-3 POWER BASE CHAIRITISubstantially Equivalent
K982066MP-3 POWER BASE CHAIRITISubstantially Equivalent
K952042TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEERINISubstantially Equivalent
K933662MERITS WHEELCHAIRITISubstantially Equivalent for Some Indications
K933406TRAVEL EASEIORSubstantially Equivalent

Registered establishments

FDA registered establishments for Merits Health Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96803331000334118MERITS HEALTH PRODUCTS CO., LTD.NO. 18, JINGKE RD., T.P.M.T. PARK, TAICHUNG CITY 40852 TW2026and 13 more, listed in full below
30308224913030822491MERITS HEALTH PRODUCTS, INC.5551 E North Belt Rd Ste 189, Las Vegas, NV 89115 US2026
30451587963045158796MERITS HEALTH PRODUCTS, INC.9983 Gulf Logistics Dr Bldg 5, Fort Myers, FL 33913 US2026
10580691000221992MERITS HEALTH PRODUCTS., INC.4245 EVANS AVENUE, Fort Myers, FL 33901 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-1505-2021ScooterSeat baseplate pin has broken in the field.Class IIOpen, Classified
Z-1504-2021Power WheelchairSeat baseplate pin has broken in the field.Class IIOpen, Classified
Z-1632-2020Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.Pinion gear may disengage from track allowing lift to slip or jolt.Class IITerminated

Verification record

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