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

Upper Yokneam Northern, IL

LIFEWARD, INC. appears in FDA device records in Upper Yokneam Northern, IL. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Lifeward, 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.

  • Argo Medical Technologies, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Lifeward, Inc. in 2014.

Clearances by year, as a table
510(k) clearance decisions for Lifeward, Inc., by decision year
YearClearances
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
DEN130034REWALKPHLUnknown

Registered establishments

FDA registered establishments for Lifeward, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097670533009767053LIFEWARD, INC.2 Cabot Rd, Suite 104,, Hudson, MA 01749 US2026
30076156653007615665Lifeward LTD.3 Hatnufa St. (6th Floor), Upper Yokneam Northern 00206-9203 IL2026

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-1553-2021ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.Class IITerminated
Z-0944-2018ReWalk Personal 6.0. Catalog number: 50-20-0004.Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.Class IITerminated

Verification record

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