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
| Country | Makers |
|---|---|
| United States | 23 |
| China | 13 |
| South Korea | 6 |
| United Kingdom | 5 |
| Germany | 3 |
| Israel | 2 |
| Italy | 2 |
| Portugal | 2 |
| Netherlands | 1 |
| Hong Kong | 1 |
| Canada | 1 |
| Australia | 1 |
| Slovenia | 1 |
| Switzerland | 1 |
| Japan | 1 |
| Belgium | 1 |
| Singapore | 1 |
| Taiwan | 1 |
| France | 1 |
| Mexico | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lode B.V. | Groningen, Netherlands | Manufacturer | 2 | December 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| ActiGraph L.L.C. | Pensacola, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | July 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| Biometrics Ltd. | Newport Wales, United Kingdom | Manufacturer | 1 | December 11, 1996 | 0 | 0 | 0 | api.fda.gov |
| Bte Technologies | Hanover, MD, United States | Manufacturer | 1 | June 20, 1994 | 0 | 1 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | November 27, 1984 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 1 | April 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| APDM Wearable Technologies, Inc. | Portland, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BAL Inc | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bertec Corp. | Columbus, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioness Medical, Inc. | Valencia, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biosensics | Newton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blatchford Products Limited | BASINGSTOKE Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bliss Health Products Co., Ltd. | Zhongshan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bright Cloud International Corp. | Elkton, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Booguu Company Limited | Pak Shek Kok, N.T., Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celestra Health Systems Corporation | Ottawa Ontario, Canada | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celloscope, Ltd | TEL AVIV - JAFFA Central, Israel | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Co., Ltd. | Asan-si Chungnam, South Korea | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergoline GMBH | BITZ Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exer Labs, Inc. | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exosystems Inc. | Seongnam-si, Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foresite Healthcare, LLC | Maryland Heights, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GKC Manufacturing Pty Ltd | Melbourne Victoria, Australia | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gripable Ltd | Beaconsfield Buckinghamshire, United Kingdom | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Homesun Medical Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyenno Technologies Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H/P/Cosmos Sports & Medical GMBH | NUSSDORF BEI TRAUNSTEIN Bavaria, Germany | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua DK Dental Co., Ltd | HuangHua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hurotics Inc. | Dongjak District Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan City Hubei, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| InBody Co, Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Janzen And Janzen Chiropractic Corporation | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kyto Fitness Technology Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kneu Health Limited | London London, City of, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L-Tek D.O.O. | Sentjernej Ljubljana, Slovenia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M20 Co.,ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnes AG | Zurich, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Man & Company Limited | Gumi-Si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medivr.inc | Toyonaka Osaka, Japan | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medthera Inc. | Waconia, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moveup | Brussels Brussels-Capital Region, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirac, LLC | Lynchburg, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NCS Lab SRL | Carpi Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Note Electronics (dongguan) Co. Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuro Rehab VR | Fort Worth, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plethy | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| POWERbreathe International Ltd | SOUTHAM Warwickshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro2health, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prove Labs inc | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roceso Technologies Pte. Ltd. | Singapore, West South West, Singapore | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rune Labs Inc. | San Francisco, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seniorlife Technologies Inc | Bellevue, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Wanbo Technology Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Reborn Medical Devices Co.,ltd | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stridelink Inc. | Atlanta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sword Health S.A. | Porto, Portugal | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sword Health S.A. | Vila Nova de Gaia Porto, Portugal | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SWORD Health, Inc | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Virtualis | Montpellier Herault, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn De Mexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xrhealth R&D Ltd. | Tel-Aviv Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.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.