Convaid Products, Inc.: FDA filings under this applicant name

FDA lists 9 510(k) clearances under the applicant name “Convaid Products, Inc.” (first 1978, latest 2017), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 38 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
20121212
20130—
20141211
20150—
20160—
20171196
20180—
20190—
20200—
20210—
20220—
20230—
20240—
20250—
20260—

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Convaid Products, Inc. took a median 196 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.

Top product codes

Product codeDeviceSubmissions510(k) clearances
IORWheelchair, Mechanical44
LBEStroller, Adaptive33
INMChair, With Casters11
ITJWalker, Mechanical11

Review panels

Most recent Convaid Products, Inc. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K171017Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16TIOR2017-10-18196
K140416TREKKER, TREKKER TRANSITIOR2014-09-17211
K120501CHAMP CHAMP TRANSITIOR2012-09-20212
K032402RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,IOR2003-09-2451
K840250CARRIERLBE1984-02-0929
K833195UMBRELLA WALKERITJ1983-10-2738
K822992PEOPLE MOVERINM1982-10-2715
K810676CONVAID CRUISER CP4MLBE1981-03-2614
K781947STROLLER, THERAPYLBE1978-12-0413

Recalls

openFDA lists no recalls under a recalling firm named Convaid Products, Inc..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Convaid Products, Inc.?

FDA lists 9 510(k) clearances under the applicant name “Convaid Products, Inc.” (first 1978, latest 2017), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Convaid Products, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Convaid Products, Inc. is 38 days.

Which FDA product codes appear under Convaid Products, Inc.?

The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 4); LBE (Stroller, Adaptive, 3); INM (Chair, With Casters, 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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