Health & Life Co., Ltd.: FDA filings under this applicant name

FDA lists 60 510(k) clearances under the applicant name “Health & Life Co., Ltd.” (first 1999, latest 2021), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 50 days. Since 2017 the median was 145 days, against 190 days for all cleared 510(k)s in the same product codes. 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Health & Life Co., Ltd. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.

Top product codes

Review panels

• Cardiovascular (56)
• Anesthesiology (1)
• Clinical Chemistry (1)
• Gastroenterology and Urology (1)
• General Hospital (1)

Most recent Health & Life Co., Ltd. 510(k) clearances

50 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Health & Life Co., Ltd..

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Health & Life Co., Ltd. (a text match, not an official crosswalk):

• G0379 — Direct admission of patient for hospital observation care (via CAF)

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.

• Health Products, Inc. (13 510(k)s)
• Health Line International Corporation (12 510(k)s)
• Health Hero Network, Inc. (8 510(k)s)
• Health Care Mfg., Inc. (7 510(k)s)
• Health Care Innovations, Inc. (5 510(k)s)
• Health Development Corp. (5 510(k)s)
• Health Images, Inc. (5 510(k)s)
• Health Beacons, Inc. (4 510(k)s)
• Health Improvement Assoc. (4 510(k)s)
• Health Scan, Inc. (4 510(k)s)
• Health Sense Intl., Inc. (4 510(k)s)
• Health Systems Intl., Inc. (4 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Health & Life Co., Ltd.?

FDA lists 60 510(k) clearances under the applicant name “Health & Life Co., Ltd.” (first 1999, latest 2021), across 6 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Health & Life Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Health & Life Co., Ltd. is 50 days. Since 2017: 145 days, versus 190 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Health & Life Co., Ltd.?

The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 55); CAF (Nebulizer (Direct Patient Interface), 1); DQD (Stethoscope, Electronic, 1).

Next steps

• See all 60 Health & Life Co., Ltd. clearances with predicates and recalls
• Run predicate analysis for product code DXN, Health & Life Co., Ltd.'s most frequent

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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