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Data / Medical devices / Exerciser, Measuring

Exerciser, Measuring (ISD): 68 FDA-registered makers in 20 countries

68 establishments in 20 countries are registered with the FDA to make Exerciser, Measuring (product code ISD, Class 2, 21 CFR 890.5360). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 61 510(k) clearances under this code, the latest on December 21, 2020, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ISD
Device class
2
Regulation
890.5360
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States23
China13
South Korea6
United Kingdom5
Germany3
Israel2
Italy2
Portugal2
Netherlands1
Hong Kong1
Canada1
Australia1
Slovenia1
Switzerland1
Japan1
Belgium1
Singapore1
Taiwan1
France1
Mexico1

Makers of Exerciser, Measuring

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Lode B.V.Groningen, NetherlandsManufacturer2December 21, 2020000api.fda.gov
ActiGraph L.L.C.Pensacola, FL, United StatesManufacturer, Repackager or relabeler, Specification developer1July 24, 2008000api.fda.gov
Biometrics Ltd.Newport Wales, United KingdomManufacturer1December 11, 1996000api.fda.gov
Bte TechnologiesHanover, MD, United StatesManufacturer1June 20, 1994010api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1November 27, 1984000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer1April 27, 2006000api.fda.gov
APDM Wearable Technologies, Inc.Portland, OR, United StatesManufacturer0000api.fda.gov
BAL IncSunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Bertec Corp.Columbus, OH, United StatesManufacturer0000api.fda.gov
Bioness Medical, Inc.Valencia, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
BiosensicsNewton, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Blatchford Products LimitedBASINGSTOKE Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Bliss Health Products Co., Ltd.Zhongshan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Bright Cloud International Corp.Elkton, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Booguu Company LimitedPak Shek Kok, N.T., Hong KongExporter to the US, Manufacturer0000api.fda.gov
Celestra Health Systems CorporationOttawa Ontario, CanadaExporter to the US, Specification developer0000api.fda.gov
Celloscope, LtdTEL AVIV - JAFFA Central, IsraelComplaint file establishment, Manufacturer0000api.fda.gov
Chongqing Sonmol Technology Co., Ltd.Chongqing, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dreamtech Co., Ltd.Asan-si Chungnam, South KoreaContract manufacturer, Exporter to the US0000api.fda.gov
Dongguan Q & S Electronic Manufacturing Company LimitedDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
EMPATICA S.r.l.Milano, ItalyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ergoline GMBHBITZ Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Exer Labs, Inc.Denver, CO, United StatesManufacturer0000api.fda.gov
Exosystems Inc.Seongnam-si, Gyeonggi-do, South KoreaManufacturer0000api.fda.gov
Foresite Healthcare, LLCMaryland Heights, MO, United StatesManufacturer0000api.fda.gov
GKC Manufacturing Pty LtdMelbourne Victoria, AustraliaManufacturer, Repackager or relabeler0000api.fda.gov
Gripable LtdBeaconsfield Buckinghamshire, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Guangzhou Homesun Medical Technology Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Gyenno Technologies Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
H/P/Cosmos Sports & Medical GMBHNUSSDORF BEI TRAUNSTEIN Bavaria, GermanyContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Hurotics Inc.Dongjak District Seoul, South KoreaManufacturer0000api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.Xiaogan City Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
InBody Co, Ltd.Cheonan-si Chungnam, South KoreaManufacturer0000api.fda.gov
Janzen And Janzen Chiropractic CorporationOklahoma City, OK, United StatesManufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Kyto Fitness Technology Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kneu Health LimitedLondon London, City of, United KingdomSpecification developer0000api.fda.gov
L-Tek D.O.O.Sentjernej Ljubljana, SloveniaContract manufacturer0000api.fda.gov
M20 Co.,ltd.Seoul, South KoreaManufacturer0000api.fda.gov
Magnes AGZurich, SwitzerlandSpecification developer0000api.fda.gov
Man & Company LimitedGumi-Si Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Medivr.incToyonaka Osaka, JapanComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Medthera Inc.Waconia, MN, United StatesSpecification developer0000api.fda.gov
MoveupBrussels Brussels-Capital Region, BelgiumManufacturer0000api.fda.gov
Mirac, LLCLynchburg, OH, United StatesContract manufacturer0000api.fda.gov
Nantong Kangjinchen Medical Equipment Co., Ltd.Nantong Jiangsu, ChinaManufacturer0000api.fda.gov
NCS Lab SRLCarpi Modena, ItalyManufacturer0000api.fda.gov
Ningbo Hanyue Medical Technology Co.,ltdCIXI CITY Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Note Electronics (dongguan) Co. LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Neuro Rehab VRFort Worth, TX, United StatesManufacturer0000api.fda.gov
PlethySanta Clara, CA, United StatesManufacturer0000api.fda.gov
POWERbreathe International LtdSOUTHAM Warwickshire, United KingdomManufacturer0000api.fda.gov
Pro2health, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Prove Labs incBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Roceso Technologies Pte. Ltd.Singapore, West South West, SingaporeManufacturer, Specification developer0000api.fda.gov
Rune Labs Inc.San Francisco, CA, United StatesManufacturer0000api.fda.gov
Seniorlife Technologies IncBellevue, WA, United StatesManufacturer0000api.fda.gov
Shanghai Wanbo Technology Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltdShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Stridelink Inc.Atlanta, GA, United StatesManufacturer0000api.fda.gov
Sword Health S.A.Porto, PortugalManufacturer0000api.fda.gov
Sword Health S.A.Vila Nova de Gaia Porto, PortugalManufacturer0000api.fda.gov
SWORD Health, IncSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
VirtualisMontpellier Herault, FranceManufacturer0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Xrhealth R&D Ltd.Tel-Aviv Tel Aviv, IsraelManufacturer0000api.fda.gov

Updated December 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.